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MULTIFUNCTIONAL FORMULATIONS AND METHODS TO CONTROL DERMATITIS AND PRURITUS

20190374552 ยท 2019-12-12

    Inventors

    Cpc classification

    International classification

    Abstract

    This disclosure relates to multifunctional formulations, methods of manufacture and methods of use of natural topical and oral compositions to treat various dermatitis and pruritus conditions in mammals. In particular, this disclosure relates to a multifunctional topical pharmaceutical composition effective to treat dermatitis and associated pruritus comprising at least one natural plant extract TRPV1 antagonist, at least one natural plant extract is a TRPA1 antagonist, and a carrier. Also, in particular, this disclosure also relates to a multifunctional method to treat histamine induced and non-histamine dermatitis and associated pruritus in mammals from one or more of non-atopic and atopic dermatitis (AD), contact dermatitis, allergenic contact dermatitis (ACD), psoriasis, eczema, infestations, urticarial, nociceptive, neuropathic, neurogenic, psychogenic pruritus comprising treating with a composition comprising at least one natural plant extract TRPV1 antagonist, at least one natural plant extract is a TRPA1 antagonist, and a carrier.

    Claims

    1. A water-soluble topical pharmaceutical composition effective to treat dermatitis and associated pruritus comprising a natural plant extract TRPV1 antagonist, a natural plant extract TRPA1 antagonist, a natural plant extract TRPM8 agonist, a non-steroidal anti-inflammatory compound and a carrier which comprises; water, a thickening agent and a non-ionic surfactant, wherein the composition further comprises cannabinoid compound.

    2-7. (canceled)

    8. The composition of claim 1 further comprising an antibiotic.

    9. The composition of claim 1 further comprising a fungistatic compound.

    10. The composition of claim 1 in which the natural plant extract TRPV1 antagonist is selected from one or more fatty acids of the group comprising: an Omega-9 fatty acid oleic acid (OL); an Omega-3 fatty acid a-linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA).

    11. (canceled)

    12. The composition of claim 1 where the TRV1 antagonist is selected from one or more of the naturally occurring compounds, comprising: flax seed oil, apricot kernel oil, cannabidiol (CBD), cannabigerol (CBG), cannabidivarin (CBDV), and 9-THC Propyl Analogue (THC-V).

    13. The composition of claim 1 in which the natural plant extract TRPA1 antagonist is selected from one or more naturally occurring compounds comprising: borneol, 1,8-cineole, camphor, ()-fenchone, fenchyl alcohol, 2-methylisoborneol, norcamphor, cannabidiol (CBD), cannabichromene (CBC) and Cannabinol (CBN).

    14. The composition of claim 13 where the source of the naturally occurring TRPA1 antagonists is from one or more of the following essential oils: Inula essential oil (Inula graveolens; Thyme borneol essential oil (Thymus satureioides); Gudun Oil (Dipterocarpus Turbinatus), Camphorwood essential oil, (Cinnamomum camphora. Chvar. Borneol), Camphor laurel essential oil (Cinnamomum camphora), Indonesian cinnamon essential oil (Cinnamomun burmanni), Sage essential oil (Salvia Officinalis), Eucalyptus essential oil (Eucalyptus polybractea, Eucalyptus camaldulensis, Eucalyptus smithii, Eucalyptus globulus, Eucalyptus radiate, Eucalyptus spp.), Rosemary essential oil (cineole type) (Rosmarinus Officinalis), Helichrysum gymnocephalum, Bay Laurel Essential Oil (Laurus nobilis), Cannabis essential oil (Cannabis sativa, Cannabis indica, and Cannabis ruderalis), Spanish Sage essential oil (Salvia lavandulifolia).

    15-16. (canceled)

    17. The composition of claim 1 in which the natural plant extract TRPM8 agonist is 1-menthol.

    18. The composition of claim 17 in which the source of 1-menthol is selected from one or more essential oils selected from the group of: Mentha spp., including, but not limited to: Mentha piperita; and Mentha arvensis.

    19-20. (cancelled)

    21. The composition of claim 1, where the non-steroidal anti-inflammatory compound is methyl salicylate.

    22. The composition of claim 21 in which the source of the methyl salicylate is an essential oil from Gaultheria procumbens (wintergreen).

    23. The composition of claim 1 in which the cannabinoid compounds is selected from one or more of the group comprising cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), cannabidivarin (CBDV), and delta9-tetrahydrocannabinol (THC).

    24. The composition of claim 1 where the cannabinoid compound is cannabidiol.

    25-28. (canceled)

    29. A non-ionic surfactant of claim 1 wherein the surfactant is selected from a group comprising: polyoxyethylene (20) sorbitan monolaurate; polyoxyethylene (20) sorbitan monooleate; polyoxyethylene (20) sorbitan monopalmitate; polyoxyethylene (20) sorbitan monostearate; sorbitan trioctadecanoate; polyglyceryl-3 Stearate; polyglyceryl-3 palmitate; polyglyceryl-2 laurate; polyglyceryl-5 laurate; polyglyceryl-5 oleate; polyglyceryl-5 dioleate; and polyglyceryl-10 diisostearate.

    30. A thickening agent composition of claim 27 wherein the thickening agent is selected from a carbomer, cacia, alginic acid, bentonite, carboxymethyl cellulose, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, magnesium aluminum silicate (Veegum), methylcellulose, poloxamers (Pluronics), polyvinyl alcohol, sodium alginate, tragacanth, guar gum, and xanthan gum.

    31. The composition of claim 30 where the thickener is the carbomer sodium polyacrylate.

    32-79. (canceled)

    80. A multifunctional method to treat dermatitis and associated pruritus comprising a natural plant extract TRPV1 antagonist, a natural plant extract is a TRPA1 antagonist, a natural plant extract TRPM8 agonist, a non-steroidal anti-inflammatory compound and a carrier which comprises water, a thickening agent and a non-ionic surfactant, optionally sodium hyaluronate, optionally a cannabinoid compound, optionally one or more antihistamine compounds, optionally one or more topical steroids, optionally one or more antibiotic compounds and optionally one or more fungistatic compounds, comprising: a) about 0.5 to about 10% by weight of a natural plant extract TRPV1 antagonist; b) about 0.5 to about 10% by weight of a natural plant extract TRPA1 antagonist; c) about 0.5 to about 10% by weight of a natural plant extract TRPM8 agonist; d) about 0.01 to about 3.00% by weight of a natural plant extract non-steroidal anti-inflammatory compound; e) a carrier comprising about 80 to about 97 water, about 0.05 to about 2.5% by weight of a non-ionic surfactant and about 0.1 to about 5.0% of a thickening agent; f) optionally, about 0.001 to about 1.0% of one or more cannabinoid compounds; g) optionally from about 0.01 to about 1.0% sodium hyaluronate h) optionally from about 0.1 to about 2.0% of one or more antihistamine compounds i) optionally from about 0.1 to about 2.5% of one or more topical steroid compounds; j) optionally from 0.5 g/mL to approximately 700 g/mL of one or more antibiotic compounds; and k) optionally from 0.1 to approximately 5.0% of one or more fungistatic compounds.

    81. The method of claim 80 wherein: component (a) comprises flax seed oil and apricot kernel oil; component (b) comprises borneol; component (c) comprises 1-menthol; component (d) comprises methyl salicylate; component (e) comprises a carrier comprising about 80 to about 97% water, about 0.05 to about 2.5% by weight of a non-ionic surfactant and about 0.1 to about 5.0% of a thickening agent; component (f) comprises cannabidiol; component (g) comprises sodium hyaluronate; component (h) comprises diphenhydramine hydrochloride; component (i) comprises hydrocortisone; component (j) comprises a mixture of bacitracin, neomycin and polymyxin B sulfate; component (k) comprises miconazole nitrate.

    82-152. (canceled)

    153. A composition of claim 1, further comprising: a) about 0.5 to about 10% by weight of a natural plant extract TRPV1 antagonist; b) about 0.5 to about 10% by weight of a natural plant extract TRPA1 antagonist; c) about 0.5 to about 10% by weight of a natural plant extract TRPM8 agonist; d) about 0.01 to about 3.00% by weight of a natural plant extract non-steroidal anti-inflammatory compound; e) a carrier comprising about 80 to about 97% water, about 0.05 to about 2.5% by weight of a non-ionic surfactant and about 0.1 to about 5.0% of a thickening agent; f) optionally, about 0.001 to about 1.0% of one or more cannabinoid compounds; and g) optionally, about 0.01 to about 1.0% sodium hyaluronate.

    154. A composition as in claim 153 wherein: component (a) comprises flax seed oil and apricot kernel oil; component (b) comprises borneol; component (c) comprises 1-menthol; component (d) comprises methyl salicylate; component (e) comprises water, the non-ionic surfactant polyoxyethylene (20) sorbitan monolaurate and sodium polyacrylate component (f) comprises cannabidiol; and component (g) comprises sodium hyaluronate.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0081] FIG. 1 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, Omega-3 and Omega-9 fatty acids, polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate and water for the composition in accordance with Example 1.

    [0082] FIG. 2 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, Linum usitatissimum oil, Prunus armeniaca oil, polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate and water in accordance with Example 2.

    [0083] FIG. 3 shows a composition used in the manufacture of a topical gel to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, Omega-3 and Omega-9 fatty acids, sodium polyacrylate and water in accordance with Example 3.

    [0084] FIG. 4 shows a composition used in the manufacture of a topical gel to treat dermatitis and pruritus comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, Linum usitatissimum oil, Prunus armeniaca oil, sodium polyacrylate and water in accordance with Example 4.

    [0085] FIG. 5 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, Omega-3 and Omega-9 fatty acids, polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate and water for the composition in accordance with Example 5.

    [0086] FIG. 6 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, Linum usitatissimum oil, Prunus armeniaca oil, Mentha arvensis essential oil, polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate and water in accordance with Example 6.

    [0087] FIG. 7 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, Linum usitatissimum oil, Prunus armeniaca oil, sodium hyaluronate, Mentha arvensis essential oil, polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate and water in accordance with Example 7.

    [0088] FIG. 8 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: borneol; 1,8-cineole; 1-menthol; an oil containing one or more of CBD, CBC and CBG; Omega-3 and Omega-9 fatty acids; polyoxyethylene (20) sorbitan monolaurate; sodium polyacrylate; and water in accordance with Example 8.

    [0089] FIG. 9 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, Linum usitatissimum oil, Prunus armeniaca oil, Mentha arvensis essential oil, Cannabis sativa L. essential oil and Omega-3 and Omega-9 fatty acids, polyoxy ethylene (20) sorbitan monolaurate; sodium polyacrylate; and water in accordance with Example 9.

    [0090] FIG. 10 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, a NSAID, Omega-3 and Omega-9 fatty acids, polyoxyethylene (20) sorbitan monolaurate; sodium polyacrylate; and water in accordance with Example 10.

    [0091] FIG. 11 shows a composition used in the manufacture of a topical cream to treat dermatitis and pruritus comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, Linum usitatissimum oil, Prunus armeniaca oil, Mentha arvensis essential oil, Gaultheria procumbens essential oil, polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate, and water in accordance with Example 11.

    [0092] FIG. 12 shows a composition used in the manufacture of a topical cream to remove urushiol oil from the skin following exposure to poison ivy, poison oak and poison sumac and to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, d-limonene, PEG-6 Cocoa Fatty Acid surfactant, Omega-3 and Omega-9 fatty acids, polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate, hydrogenated vegetable oil beads (125 to 750 size range), and water in accordance with Example 12.

    [0093] FIG. 13 shows a composition used in the manufacture of a topical cream to treat Acute Contact Dermatitis following exposure to poison ivy, poison oak and poison sumac comprising: borneol, 1,8-cineole, 1-menthol, sodium hyaluronate, Omega-3 and Omega-9 fatty acids, poly oxy ethylene (20) sorbitan monolaurate, sodium poly aery late, and water in accordance with Example 13.

    [0094] FIG. 14 shows a composition used in the manufacture of a topical spray liquid to treat to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, isopropyl alcohol, water, and Omega-3 and Omega-9 fatty acids in accordance with Example 14.

    [0095] FIG. 15 shows a composition used in the manufacture of a topical balm to treat to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, waxes and plant oils and butters, and Omega-3 and Omega-9 fatty acids in accordance with Example 15.

    [0096] FIG. 16 shows a composition used in the manufacture of a topical cream to treat dermatitis, pruritus and fungal infections comprising: borneol, 1,8-cineole, 1-menthol, methyl salicylate, Omega-3 and Omega-9 fatty acids, a fungistatic compound; polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate, and water in accordance with Example 16.

    [0097] FIG. 17 shows a composition used in the manufacture of a topical cream to treat dermatitis, pruritus and fungal infections comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, Linum usitatissimum oil, Prunus armeniaca oil, Mentha arvensis essential oil, Gaultheria procumbens essential oil, miconazole nitrate, polyoxyethylene (20) sorbitan monolaurate, sodium polyacrylate, and water in accordance with Example 17.

    [0098] FIG. 18 shows a composition used in the manufacture of an orally consumed nutritional supplement to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, Omega-3 and Omega-9 fatty acids, for the composition in accordance with Example 18.

    [0099] FIG. 19 shows a composition used in the manufacture of an orally consumed nutritional supplement to treat dermatitis and pruritus comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, and Fish Oil in accordance with Example 19.

    [0100] FIG. 20 shows a composition used in the manufacture of an orally consumed nutritional supplement to treat dermatitis and pruritus comprising: Thymus satureioides essential oil, Rosmarinus Officinalis essential oil, Fish Oil and Vitamin D3 in accordance with Example 20.

    DESCRIPTION OF THE EMBODIMENTS

    [0101] Surprisingly, it has been found that the topical administration of gels, creams, balms, waxes and sprays manufactured from natural plant extracts that are TRPV1 and TRPA1 antagonists are efficacious in the reduction of dermatitis and pruritus conditions in mammals. In particular, this disclosure relates to the use of compositions comprised of natural plant extract compounds that are multifunctional TRPA1 and TRPV1 ion channel antagonists, CGRP antagonists, cannabinoid CB2 antagonists, TRPM-8 agonists, MrgprCl 1 and MrgprA3-coupled protein receptor antagonists, cytokine thymic stromal lymphopoietin receptor (TSLPR) inhibitors, other cytokine inhibitors and COX-2 inhibitors. Further, these multifunctional compositions used to treat dermatitis and pruritus were found to be efficacious with the addition of steroidal compounds, cannabinoid compounds, antibacterial or antifungal compounds. Surprising rapidly elimination of symptoms of dermatitis and pruritus with treatment by these multifunctional compositions indicates a cure of the cause of the disease rather than only the alleviation of symptoms by products currently available.

    [0102] This disclosure relates in part compositions for the treatment of dermatitis, pruritus, as well as fungal and bacterial infections of the skin, which are more effective than existing compositions and products. Dermatitis and pruritus conditions and diseases that are treated with the compositions in this disclosure include, but are not limited to: atopic dermatitis (AD); allergic contact dermatitis (ACD); eczema, dyshidrotic eczema; irritant contact dermatitis; neurodermatitis; perioral dermatitis; psoriasis; insect bites, infestations (e.g. scabies, pediculosis); seborrheic dermatitis; stasis dermatitis; and urticaria (a rash of round, red welts on the skin that itch intensely, sometimes with dangerous swelling, caused by an allergic reaction, typically to specific foods, also known as hives); angioedema; histamine itch, non-histamine itch and dermal fungal and bacterial infections.

    [0103] This disclosure includes compositions, methods of use and manufacture of multifunctional nutritional supplements and other orally consumed drugs that are TRPV1 and TRPA1 antagonists and preferably contain the Omega-3 fatty acids; EPA (eicosapentaenoic acid) and DHA (docosahexanenoic acid). Optionally, the oral formulations may contain one or more of the following, comprising: an Omega-9 fatty acid oleic acid (OL); an Omega-3 fatty acid a-linolenic acid (ALA); and an Omega-6 fatty acid linoleic acid (LA). Many plant and animal oils contain an Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid a-linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA) DHA (docosahexanenoic acid). Preferable natural sources of an Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid a-linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA) include fish, crustacean and plant sources.

    [0104] This disclosure also relates in part to compositions and methods of use and manufacture of topical gels, creams, balms, waxes and sprays for the treatment of dermatitis, pruritus, as well as fungal and bacterial infections of the skin, that are more effective than existing compositions and products. Dermatitis and pruritus conditions and diseases that are treated with the compositions in this disclosure include, but are not limited to: atopic dermatitis (AD); allergic contact dermatitis (ACD); eczema, dyshidrotic eczema; irritant contact dermatitis; neurodermatitis; perioral dermatitis; psoriasis; infestations (e.g. scabies, pediculosis); seborrheic dermatitis; stasis dermatitis; and urticaria (a rash of round, red welts on the skin that itch intensely, sometimes with dangerous swelling, caused by an allergic reaction, typically to specific foods, also known as hives); angioedema; histamine itch, non-histamine itch and dermal fungal and bacterial infections.

    [0105] In one embodiment of the present disclosure is a topical pharmaceutical composition effective to treat dermatitis and associated pruritus comprising at least one natural plant extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist and a carrier. While the natural plant extract TRPV1 antagonist can be selected from any Omega-3 and Omega-9 containing fatty acid natural plant extract, preferably they are comprised of one or more fatty acids of the group comprising: an Omega-9 fatty acid oleic acid (OL); an Omega-3 fatty acid a-linolenic acid (ALA); an Omega-6 fatty acid linoleic acid (LA); and an Omega-3 fatty acid eicosapentaenoic acid (EPA). Many plant and animal oils contain an Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid -linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA). Preferable natural sources of an Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid a-linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA) are fixed seed plant oils selected from one or more of the group comprising but not limited to: flaxseed oil; canola oil; perilla seed oil; sunflower oil; apricot kernel oil; black seed oil; grapeseed oil; rosehip oil; safflower oil hempseed oil; soybean oil; wheat germ oil and evening primrose oil. It is well known in the art that many more plant and animal oils comprise one or more of an Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid a-linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA). This disclosure can include any oil that contains one or more of these compounds. Preferable oils are those that contain the highest concentrations of one or more of the group comprising, Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid a-linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA).

    [0106] In yet another embodiment of the present disclosure, the preferred natural plant extract fixed seed oils are from flaxseed oil and apricot kernel oil.

    [0107] In yet another embodiment of the present disclosure are oral pharmaceutical compositions effective to treat dermatitis and associated pruritus comprising at least one natural plant, crustacean or fish extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist and optionally a carrier. The natural plant, crustacean or fish extract TRPV1 antagonist can be selected from any Omega-3 and Omega-9 containing fatty acid natural plant extract and preferably they are comprised of one or more fatty acids of the group comprising: an Omega-9 fatty acid oleic acid (OL); an Omega-3 fatty acid a-linolenic acid (ALA); an Omega-6 fatty acid linoleic acid (LA); and an Omega-3 fatty acid eicosapentaenoic acid (EPA). Preferable natural sources of an Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid -linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA) are fixed seed plant oils selected from one or more of the group comprising but not limited to: flaxseed oil; canola oil; perilla seed oil; sunflower oil; apricot kernel oil; black seed oil; grapeseed oil; rosehip oil; safflower oil hempseed oil; soybean oil; wheat germ oil and evening primrose oil. Preferable natural sources of and an Omega-3 fatty acid eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are from fish and crustacean oils. It is well known in the art that many more plant and animal oils comprise one or more of an Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid -linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA). This disclosure can include any oil that contains one or more of these compounds. Preferable oils are those that contain the highest concentrations of one or more of the group comprising, Omega-9 fatty acid oleic acid (OL), an Omega-3 fatty acid a-linolenic acid (ALA), an Omega-6 fatty acid linoleic acid (LA), and an Omega-3 fatty acid eicosapentaenoic acid (EPA).

    [0108] In one embodiment of the present disclosure, the natural plant extract TRPA1 antagonist is selected from one or more naturally occurring compounds comprising but not limited to the group: borneol; 1,8-cineole; camphor; ()-fenchone; fenchyl alcohol; 2-methylisoborneol and norcamphor.

    [0109] In another embodiment of this present disclosure, the source of the naturally occurring TRPA1 antagonists is from one or more essential oils but not limited to the group: Inula essential oil (Inula graveolens; Thyme borneol essential oil Thymus satureioides; Gurjun Oil (Dipterocarpus Turbinatus); Camphorwood essential oil (Cinnamomum camphora Chvar. Borneol); Camphor laurel essential oil (Cinnamomum camphora); Indonesian cinnamon essential oil (Cinnamomun burmanni); Sage essential oil (Salvia Officinalis); Eucalyptus essential oil (Eucalyptus polybractea, Eucalyptus camaldulensis, Eucalyptus smithii, Eucalyptus globulus, Eucalyptus radiate, Eucalyptus spp.); Rosemary essential oil (cineole type) (Rosmarinus Officinalis); Helichrysum gymnocephalum; Bay Laurel Essential Oil (Laurus nobilis); Cannabis essential oil (Cannabis sativa, Cannabis indica, and Cannabis ruder alis); Spanish Sage essential oil (Salvia lavandulifolia).

    [0110] In yet another embodiment of the present disclosure, the preferred natural plant extract TRPA1 antagonist is borneol. The preferred source of the natural plant extract TRPA1 antagonist is from Thyme borneol essential oil (Thymus satureioides). An additional source of borneol can be from a synthetic source. In addition to being a TRPA1 antagonist, borneol provides fungistatic and antibacterial properties of compositions in this instant disclosure. In this current disclosure borneol may also be included in compositions to inhibit or block IL-1 , IL-4, IL-5, IL-6, and TNF-.

    [0111] In yet another embodiment of the present disclosure, an additional preferred natural plant extract TRPA1 antagonist is 1,8-cineole. The preferred source of the natural plant extract TRPA1 antagonist is from Rosemary essential oil (cineole type) (Rosmarinus Officinalis). In addition to being a TRPA1. antagonist, 1,8-cineole provides fungistatic properties of compositions in this instant disclosure. In this current disclosure 1,8-cineole may also be in included in compositions to block (IL)-4, IL-6, IL-8, IL-13 and IL-17A.

    [0112] In another embodiment of the present disclosure includes pharmaceutical composition and a method to treat dermatitis and pruritus comprises at least one natural plant, fish or crustacean extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist and a carrier and at least one natural plant extract TRPM8 agonist. Surprisingly, the addition of a TRPM8 agonist to this a composition of at least one natural plant extract TRPV1 antagonist and at least one natural plant extract TRPA1 antagonist to treat dermatitis and pruritus significantly increases the effectiveness of the treatment and leads to a more rapid cure of dermatitis and pruritus.

    [0113] In yet another embodiment of the present disclosure the TRPM8 agonist is 1-menthol. The source of 1-menthol can be either synthetic or natural. The preferred source of 1-menthol is natural and is selected from the group of one or more essential oils of Mentha spp.: including, but not limited to, Mentha piperita; and Mentha arvensis. Because 1-menthol is also a known TRPA1 agonist in humans, (which would not be advantageous in these compositions as TRPA1 is known to be a cause of pruritus) the addition of natural plant extract TRPA1 antagonists helps to block the TRPA1 activation caused by menthol.

    [0114] In another embodiment of the present disclosure further comprises sodium hyaluronate, a salt of hyaluronic acid. Hyaluronic acid has recently been discovered to be a TRPV1 antagonist associated with nociception. Sodium hyaluronate is a biotechnology manufactured natural compound that is a TRPV1 antagonist and an inhibitor of IL-I, IL-8, IL-6, prostaglandin E2 (PGE2), and tumor necrosis factor (TNF-). Sodium hyaluronate alone has been successfully used alone to treat radiation recall dermatitis and facial seborrheic dermatitis,

    [0115] In yet another embodiment this present disclosure is a nonsteroidal anti-inflammatory agent (NSAID) in pharmaceutical compositions and a methods to treat dermatitis and pruritus comprising at least one natural plant extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist, a carrier and optionally a TRPMS agonist, and optionally sodium hyaluronate. The NSAID agent can be a naturally occurring compound or one that is synthetically manufactured. Synthetically manufactured NSAIDs that are included in compositions and methods to treat dermatitis and pruritus in this disclosure can be selected from the group, but not limited to arthrotec, celecoxib, diclofenac, rofecoxib, vadecoxib, naproxen, ketoprofen, felbinac, ibuprofen, piroxicam, benzydamine, indomethacin and diclofenac.

    [0116] In yet another embodiment of this present disclosure the preferred NSAID is diclofenac.

    [0117] In yet another embodiment of this present disclosure a naturally occurring NSAID prodrug is methyl salicylate. While methyl salicylate is a naturally occurring compound found in the essential oil from Gaultheria procumbens (wintergreen), it can also be synthetically manufactured and used in compositions of this disclosure. Because methyl salicylate is also a known TRPA1 agonist (which would not be advantageous in these compositions as TRPA1 is known to be a cause of pruritus) the addition of natural plant extract TRPA1 antagonists helps to block the TRPA1 activation caused by methyl salicylate. Methyl salicylate also increases skin penetration of chemicals topically applied in formulations of this instant disclosure, as well as providing fungistatic properties.

    [0118] In another embodiment this present disclosure cannabinoid compounds are included in pharmaceutical compositions and a methods to treat dermatitis and pruritus comprising at least one natural plant, fish or crustacean extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist, a carrier, optionally a TRPM8 agonist, optionally sodium hyaluronate and optionally a NSAID.

    [0119] In yet another embodiment of this present disclosure cannabinoid compounds are selected from one or more of the group comprising: cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), cannabidivarin (CBDV), and delta9-tetrahydrocannabinol (THC).

    [0120] In yet another embodiment of this present disclosure preferred cannabinoid compound is cannabidiol.

    [0121] In another embodiment this present disclosure is an antihistamine compound in pharmaceutical compositions and a method to treat dermatitis and pruritus comprising at least one natural plant, fish or crustacean extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist, a carrier optionally a TRPM8 agonist, optionally sodium hyaluronate, optionally a NSAID and optionally a cannabinoid compound. Preferred anti histamines used in compositions associated with patent are diphenhydramine and chlorpheniramine, doxepin, with diphenhydramine being the most preferred.

    [0122] In another embodiment this present disclosure is a steroid compound in pharmaceutical compositions and a methods to treat dermatitis and pruritus comprising at least one natural plant, fish or crustacean extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist, a carrier optionally a TRPM8 agonist and optionally sodium hyaluronate. Steroid compounds that are included in compositions and methods to treat dermatitis and pruritus can be selected from the group comprising, but not limited to; triamcinolone; fluocinolone; prednicarbate; desonide; betamethasone; hydrocortisone; diflorasone; desoximetasone; mometasone; clobetasol;clocortolone; and halcinonide.

    [0123] In yet another embodiment of this present disclosure the preferred steroid compound is hydrocortisone.

    [0124] In another embodiment this present disclosure is an antibiotic compound in pharmaceutical compositions and a methods to treat dermatitis, pruritus and bacterial infections of the skin, comprising at least one natural plant, fish or crustacean extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist, a carrier optionally a TRPM8 agonist, optionally sodium hyaluronate, and optionally a steroid. Antibiotic compounds that are included in compositions and methods to treat dermatitis and pruritus can be selected from the group comprising, but not limited to; bacitracin, chlorhexidine gluconate, mupirocin, neomycin, polymyxin B and retapamulin. In this present disclosure the preferred antibiotic is a mixture of neomycin, bacitracin and polymyxin B.

    [0125] In another embodiment this present disclosure is a fungistatic compound in pharmaceutical compositions and a methods to treat dermatitis, pruritus and dermal fungal infections comprising at least one natural plant, fish or crustacean extract TRPV1 antagonist, at least one natural plant extract TRPA1 antagonist, a carrier, optionally a TRPM8 agonist, optionally methyl salicylate, and optionally an antibiotic compound. Fungistatic compounds that are included in compositions and methods to treat dermatitis, pruritus and topical fungal infections can be selected from the group comprising, but not limited to; fluconazole, itraconazole, clotrimazole, miconazole, ketoconazole, econazole, terbinafine, naftifine, butenafine and amphotericin.

    [0126] In yet another embodiment of this present disclosure the preferred fungistatic compound is miconazole nitrate.

    [0127] In one embodiment of the present disclosure, compositions comprise sprayable topical liquids for the treatment of dermatitis and pruritus wherein a major portion by weight of said carrier is a hydrophilic alcohol. In a preferred aspect of this present disclosure the hydrophilic alcohol is isopropyl alcohol. The sprayable liquid may be applied from a hand-pumped spray bottle or alternatively, an aerosol from an inert gas pressurized container spray. The pressurized container may comprise a single or dual bag-on-valve system to eliminate contact of the liquid with the propellant compressed gas. A person ordinarily skilled in the art would recognize and understand that all of the formulations and examples shown in this disclosure that comprise topically applied liquids that can also be sprayed, could also be made into creams, gels, liquids with the viscosity essentially of that of water, sprays, balms, waxes and massage oils and incorporated into skin patch products for the treatment of dermatitis, pruritus and bacterial and fungal skin infections.

    [0128] In one embodiment of the present disclosure the composition comprises a viscous topical gel for the treatment of dermatitis and pruritus wherein the carrier forms a viscous gel comprising at least one thickening agent and water. A thickening agent can be selected from the group, but not limited to; carbomer, cacia, alginic acid, bentonite, carboxymethyl cellulose, ethylcellulose, hydroxy ethyl cellulose, hydroxypropyl cellulose, magnesium aluminum silicate (Veegum), methylcellulose, poloxamers (Pluronics), polyvinyl alcohol, sodium alginate, tragacanth, guar gum, and xanthan gum. In a preferred embodiment of this present disclosure the preferred thickener is the carbomer sodium polyacrylate. In one aspect of this present disclosure, the carrier is a viscous gel composition wherein the thickening agent is mixed with the oil phase, comprising one or more of the hydrophobic components of the composition, then mixed with water. A person ordinarily skilled in the art would recognize and understand that all of the formulations and examples shown in this disclosure that comprise gels, could also be made into creams, liquids with the viscosity essentially of that of water, sprays, balms, waxes and massage oils and incorporated into skin patch products for the treatment of dermatitis, pruritus and bacterial and fungal skin infections.

    [0129] In another embodiment of the present disclosure the composition comprises a viscous topical cream for the treatment of dermatitis and pruritus wherein the carrier forms a viscous cream comprising at least one thickening agent, a surfactant and water. In one aspect of this disclosure the surfactant comprises a non-ionic surfactant. The non-ionic surfactant can be selected from a group comprising but not limited to: poly oxy ethylene (20) sorbitan monolaurate; polyoxyethylene (20) sorbitan monooleate; poly oxy ethylene (20) sorbitan monopalmitate; polyoxyethylene (20) sorbitan monostearate; sorbitan trioctadecanoate; polyglyceryl-3 stearate; polyglyceryl-3 palmitate; polyglyceryl-2 laurate; polyglyceryl-5 laurate; polyglyceryl-5 oleate; polyglyceryl-5 dioleate; and poly glyceryl-10 diisostearate. In a preferred embodiment of this present disclosure the viscous cream is comprised of the surfactant polyoxyethylene (20) sorbitan monolaurate, the thickening agent sodium polyacrylate and water. In one aspect of this present disclosure, the carrier is a viscous cream-like gel composition wherein the thickening agent and the surfactant are mixed with the oil phase, comprising one or more of the hydrophobic components of the composition, then mixed with water. For the purpose of this disclosure the gel is transparent and the cream is not transparent to light. A person ordinarily skilled in the art would recognize and understand that all of the formulations and examples shown in this disclosure that comprise creams, could also be made into gels, liquids with the viscosity essentially of that of water, sprays, balms, waxes, massage oils and incorporated into skin patch products for the treatment of dermatitis, pruritus and bacterial and fungal skin infections.

    [0130] Yet another embodiment of the present disclosure the composition comprises a hydrophobic topical wax for the treatment of dermatitis and pruritus wherein the carrier forms a wax, comprising at least one wax and optionally, at least one oil and an oil butter. In one aspect of the present disclosure wax is selected from beeswax, candelilla wax, camauba wax and jojoba wax and the fixed seed oil is one or more of the group, apricot kernel oil, black seed oil; flaxseed oil, hemp oil, kiwifruit seed oil, olive oil, pumpkin seed oil sweet almond oil and walnut oil. In another aspect of this present disclosure, the oil butter is selected from cocoa butter, hemp seed butter, mango butter, olive butter, shea butter and sweet almond butter. In a preferred aspect of this present disclosure the preferred wax composition consists of beeswax at a concentration from approximately 25 to approximately 98% by weight, flax seed oil at a concentration from approximately 2 to approximately 75% by weight and hemp seed butter from about 3 to 75% by weight. A person ordinarily skilled in the art would recognize and understand that all of the formulations and examples shown in this disclosure that comprise waxes and balms, could also be made into gels, creams, liquids with the viscosity essentially of that of water, sprays, massage oils and incorporated into skin patch products for the treatment of dermatitis, pruritus and bacterial and fungal skin infections.

    [0131] Yet in another embodiment of the present disclosure is a composition comprising a hydrophobic topical mixture for the treatment of dermatitis and pruritus in which the carrier is a fixed plant oil or seed oil or a mixture of fixed plant and/or seed oils to form a therapeutic massage oil. In one embodiment of the present disclosure the fixed plant and seed oils is one or more of sweet almond oil, flax seed oil, evening primrose oil, jojoba oil, apricot kernel oil, black seed oil; grape seed oil, hemp seed oil, hemp oil. In a preferred embodiment of this present disclosure the TRPV1 antagonist fixed plant oils and seed oils composition comprises sweet almond oil (29.89%), grape seed oil (40.11%), apricot kernel oil (13.04%), hemp seed oil (10.87%), evening primrose oil (2.72%) and jojoba oil (2.72%) and the TRPA1 antagonists are rosemary essential oil (0.27%) and thyme essential oil (0.27%), the TRPM8 agonist is peppermint essential oil (0.27%) and the COX-2 inhibitor is wintergreen essential oil (0.27%). The pH of healthy skin is approximately 4.7. The pH of the compositions in this present disclosure can be from pH of approximately 4.5 up to a pH of approximately 7.3. Activation of TRPM8 does not appear to be affected over this pH range. A person ordinarily skilled in the art would recognize and understand that all of the formulations and examples shown in this disclosure that comprise therapeutic massage oils, could also be made into creams, liquids with the viscosity essentially of that of water, sprays, balms, waxes and incorporated into skin patch products for the treatment of dermatitis, pruritus and bacterial and fungal skin infections.

    [0132] With the exception of balms and waxes disclosed in this present disclosure, all of the compositions can be manufactured at normal ambient temperatures and pressures typically varying from 50 F. (10 C.) to 100 F. (37.8 C.), without limiting the effectiveness of the final formations.

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    [0212] The following examples illustrate the present disclosure but are not intended to limit scope of the compositions, the methods of manufacture and use of the topical analgesics as described above. Temperature are given in degrees centigrade ( C.) and unless otherwise noted all temperatures are at 25 C.

    Example 1

    [0213] A composition and method of manufacture of a topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, and Omega-3 and Omega-9 fatty acids for the composition presented in FIG. 1 consists of mixing an amount sodium polyacrylate and poly oxy ethylene (20) sorbitan monolaurate with the oil phase components of the composition to dissolve the sodium polyacrylate then adding an amount of water, such that a stable single phase homogeneous cream results. Mixing is limited to that required to dissolve the sodium polyacrylate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous cream and to minimize volatilization of borneol and 1,8-cineole. Methods of use of the composition of the topical cream given in this Example 1 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The topical cream composition in this Example 1 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole and borneol presented in FIG. 1. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 2

    [0214] A preferred composition and method of manufacture of the topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole and Omega-3 and Omega-9 fatty acids is presented in this Example 2. Manufacturing consists of mixing the oil phase components comprising 20.0 g Thymus satureioides 20.0 g Rosmarinus Officinalis Essential Oil, 15.0 g Linum usitatissimum Oil and 15.0 g Prunus armeniaca with 7.6 g sodium polyacrylate, 3.8 g poly oxy ethylene (20) sorbitan monolaurate and then mixing sufficiently to dissolve the sodium polyacrylate, followed by then adding 919 g water then rapidly mixing for 2 to 5 minutes for the stable single phase homogeneous cream to form. Mixing is limited to that required to dissolve the sodium polyacrylate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous cream and to minimize volatilization of essential oils containing borneol and 1,8-cineole. Methods of use of the composition of the topical cream given in this Example 2 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The composition of a topical cream with borneol, 1,8-cineole, menthol and Omega-3 and Omega-9 fatty acids is shown in FIG. 2. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 3

    [0215] A method of manufacture of a topical gel to treat dermatitis and pruritus comprising: borneol, 1,8-cineole and Omega-3 and Omega-9 fatty acids for the composition presented in FIG. 3 consists of mixing an amount sodium polyacrylate with the oil phase components of the composition to dissolve the sodium polyacrylate then adding an amount of water, such that a stable single phase homogeneous gel results. Mixing is limited to that required to dissolve the sodium polyacryl ate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous gel and to minimize volatilization of borneol and 1,8-cineole. Methods of use of the composition of the topical gel given in this Example 3 include but are not meant to be limited to placing the gel composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the gel on the skin or wetting a patch with the gel and placing on the skin. The topical gel composition in this Example 3 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole and borneol presented in FIG. 3. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 4

    [0216] A preferred composition and method of manufacture of the topical gel to treat dermatitis and pruritus comprising: borneol, 1,8-cineole and Omega-3 and Omega-9 fatty acids is presented in this Example 4. Manufacturing consists of mixing the oil phase components comprising 20.0 g Thymus satureioides 20.0 g Rosmarinus Officinalis Essential Oil, 15.0 g Linum usitatissimum Oil and 15.0 g Prunus armeniaca with 10.0 g sodium polyacrylate and then mixing sufficiently to dissolve the sodium polyacrylate, followed by then adding 920 g water then rapidly mixing for 2 to 5 minutes for the stable single phase homogeneous gel to form. Mixing is limited to that required to dissolve the sodium polyacrylate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous gel and to minimize volatilization of essential oils containing borneol and 1,8-cineole. Methods of use of the composition of the topical gel given in this Example 4 include but are not meant to be limited to placing the gel composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the gel composition in a squeeze tube container, placing the gel composition in a hand pump bottle container and applying a therapeutic amount of the gel on the skin or wetting a patch with the gel and placing on the skin. The composition of a topical gel with borneol, 1,8-cineole, menthol and Omega-3 and Omega-9 fatty acids is shown in FIG. 4. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 5

    [0217] A method of manufacture of a topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol and Omega-3 and Omega-9 fatty acids for the composition shown in FIG. 5 consists of mixing an amount sodium polyacrylate and poly oxy ethylene (20) sorbitan monolaurate with the oil phase components of the composition to dissolve the sodium polyacrylate then adding an amount of water, such that a stable single phase homogeneous cream results. Mixing is limited to that required to dissolve the sodium polyacrylate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous cream and to minimize volatilization of borneol, 1,8-cineole and 1-menthol. Methods of use of the composition of the topical cream given in this Example 5 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The topical cream composition in this Example 5 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole, borneol and 1-menthol is shown in FIG. 5. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 6

    [0218] A preferred composition and method of manufacture of the topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol and Omega-3 and Omega-9 fatty acids is presented in this Example 6. Manufacturing consists of mixing the oil phase components comprising 20.0 g Thymus satureioides 20.0 g Rosmarinus Officinalis Essential Oil, 20.0 g Mentha arvensis essential oil 15.0 g Linum usitatissimum Oil and 15.0 g Prunus armeniaca with 7.6 g sodium polyacrylate, 3.8 g polyoxy ethylene (20) sorbitan monolaurate and then mixing sufficiently to dissolve the sodium polyacrylate, followed by then adding 899 g water then rapidly mixing for 2 to 5 minutes for the stable single phase homogeneous cream to form. Mixing is limited to that required to dissolve the sodium polyacrylate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous cream and to minimize volatilization of essential oils containing borneol, 1,8-cineole and 1-menthol. Methods of use of the composition of the topical cream given in this Example 6 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The composition of a topical cream with borneol, 1,8-cineole, 1-menthol and Omega-3 and Omega-9 fatty acids is shown in FIG. 6. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 7

    [0219] A preferred composition and method of manufacture of the topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, sodium hyaluronate and Omega-3 and Omega-9 fatty acids is presented in this Example 7. Manufacturing consists of mixing the oil phase components comprising 20.0 g Thymus satureioides 20.0 g Rosmarinus Officinalis Essential Oil, 20.0 g Mentha arvensis essential oil 15.0 g Linum usitatissimum Oil and 15.0 g Prunus armeniaca with 7.6 g sodium polyacrylate, 3.8 g polyoxy ethylene (20) sorbitan monolaurate and then mixing sufficiently to dissolve the sodium polyacrylate, followed by then adding 898 g cold water in which 0.75 g sodium hyaluronate has been previously dissolved, then rapidly mixing for 2 to 5 minutes for the stable single phase homogeneous cream to form. Mixing of the cold water phase containing sodium hyaluronate must be sufficient in intensity and duration to fully dissolve the sodium hyaluronate powder. Following this step mixing of the water phase containing the prior dissolved sodium hyaluronate with the oil phase components containing the prior dissolved sodium polyacrylate and the polyoxyethylene (20) sorbitan monolaurate, is required for a period of time (generally 2 to 5 minutes) to create the stable single phase homogeneous cream and to minimize volatilization of essential oils containing borneol, 1,8-cineole and 1-menthol. Methods of use of the composition of the topical cream given in this Example 7 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The composition of a topical cream with borneol, 1,8-cineole, 1-menthol, sodium hyaluronate and Omega-3 and Omega-9 fatty acids is shown in FIG. 7. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 8

    [0220] A method of manufacture of a topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, Omega-3 and Omega-9 fatty acids and one or more cannabinoid compounds selected from the group comprising: CBD, CBC and CBG, for the composition shown in FIG. 8. Oil containing one or more of the cannabinoid compounds; CBD, CBC and CBG is mixed with the oil phase ingredients until the CBD, CBC and CBG oil is dissolved. The following step consists of an amount sodium polyacrylate and polyoxyethylene (20) sorbitan monolaurate with the oil phase components of the composition to dissolve the sodium polyacrylate then adding an amount of water, such that a stable single phase homogeneous cream results. Mixing is limited to that required to initially dissolve the CBD, CBC and CBG oil with the other oil phase ingredients, following dissolution of the sodium polyacrylate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous cream and to minimize volatilization of borneol, 1,8-cineole and 1-menthol. Methods of use of the composition of the topical cream given in this Example 8 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The topical cream composition in this Example 8 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole, borneol and 1-menthol is shown in FIG. 8. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 9

    [0221] A preferred composition and method of manufacture of the topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, Omega-3 and Omega-9 fatty acids and one or more cannabinoid compounds selected from the group comprising CBD, CBC and CBG present in Cannabis sativa L. oil for the composition shown is shown in this Example 9. Manufacturing consists of mixing the oil phase components comprising 20.0 g Thymus satureioides essential oil, 20.0 g Rosmarinus Officinalis Essential Oil, 20.0 {circumflex over ()}Mentha arvensis essential oil 15.0 g Linum usitatissimum Oil and 15.0 g Prunus armeniaca and 0.20 g Cannabis sativa L. oil with 7.6 g sodium polyacrylate, 3.8 g poly oxy ethylene (20) sorbitan monolaurate and then mixing sufficiently to dissolve the sodium polyacrylate, followed by then adding 897 g cold water then rapidly mixing for 2 to 5 minutes for the stable single phase homogeneous cream to form. This composition provides approximately 50 mg/kg of actual CBD, CBC and CBG compounds. Other type of CBD oils with higher or lower concentrations of CBD, CBC and CBG in the Cannabis sativa L. oil can be added to this composition to result compositions similar to that in this Example 9 that have greater or lower CBD, CBC and CBG concentrations. Mixing of the oil phase ingredients to which the Cannabis sativa L. oil has been added must take place for a long enough period to completely dissolve Cannabis sativa L. oil. Mixing of the oil phase components with the sodium polyacrylate is limited to that required to dissolve the sodium polyacrylate with the oil phase components. Following this step mixing of the water phase with the oil phase components containing the prior dissolved sodium polyacrylate and the poly oxy ethylene (20) sorbitan monolaurate, is required for a period of time (generally 2 to 5 minutes) to create the stable single phase homogeneous cream and to minimize volatilization of essential oils containing borneol, 1,8-cineole and 1-menthol. Methods of use of the composition of the topical cream given in this Example 9 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The composition of a topical cream with borneol, 1,8-cineole, 1-menthol, Cannabis sativa L. oil and Omega-3 and Omega-9 fatty acids is shown in FIG. 9. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 10

    [0222] A method of manufacture of a topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, a NSAID and Omega-3 and Omega-9 fatty acids for the composition shown in this Example 10 consists of mixing an amount sodium polyacrylate and poly oxy ethylene (20) sorbitan monolaurate with the oil phase components of the composition to dissolve the sodium polyacrylate then adding an amount of water, such that a stable single phase homogeneous cream results. Mixing is limited to that required to dissolve the sodium polyacrylate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous cream and to minimize volatilization of borneol, 1,8-cineole, 1-menthol and the NSAID, if it is a volatile compound. Methods of use of the composition of the topical cream given in this Example 10 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The topical cream composition in this Example 10 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole, borneol and 1-menthol is shown in FIG. 10. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 11

    [0223] A preferred composition and method of manufacture of the topical cream to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol, Omega-3 and Omega-9 fatty acids and the NSAID compound methyl salicylate is shown in this Example 11. Manufacturing consists of mixing the oil phase components comprising 20.0 g Thymus satureioides essential oil, 20.0 g Rosmarinus Officinalis Essential Oil, 20.0 g Mentha arvensis essential oil 15.0 g Linum usitatissimum Oil, 15.0 g Prunus armeniaca and 20.00 g Gaultheria procumbens Essential Oil with 7.6 g sodium polyacrylate, 3.8 g polyoxyethylene (20) sorbitan monolaurate and then mixing sufficiently to dissolve the sodium polyacrylate, followed by then adding 879 g cold water then rapidly mixing for 2 to 5 minutes for the stable single phase homogeneous cream to form. Mixing of the oil phase components with the sodium polyacrylate is limited to that required to dissolve the sodium polyacrylate with the oil phase components. Following this step mixing of the water phase with the oil phase components containing the prior dissolved sodium polyacrylate and the polyoxyethylene (20) sorbitan monolaurate, is required for a period of time (generally 2 to 5 minutes) to create the stable single phase homogeneous cream and to minimize volatilization of essential oils containing borneol, 1,8-cineole, 1-menthol and methyl salicylate. Methods of use of the composition of the topical cream given in this Example 11 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The composition of a topical cream with borneol, 1,8-cineole, 1-menthol, Gaultheria procumbens Essential Oil and Omega-3 and Omega-9 fatty acids is shown in FIG. 11. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 12

    [0224] A composition and a method of manufacture of a topical cream, optionally with microbeads in the size range of 125 to 750, to remove urushiol oil associated with recent exposure to poison ivy, poison oak or poison sumac comprising: borneol, 1,8-cineole, 1-menthol, d-limonene, Omega-3 and Omega-9 fatty acids and PEG-9 Cocoa Fatty Acid non-ionic surfactant, and optionally 125 to 750 microbeads for the composition shown in this Example 12 consists of mixing an amount sodium polyacrylate and polyoxy ethylene (20) sorbitan monolaurate with the oil phase components of the composition to dissolve the sodium polyacrylate then adding an amount of water, such that a stable single phase homogeneous cream results. The 125 to 750 sized microbeads can be added immediately after the water is added to the oil ingredients during the mixing process. The d-limonene and the PEG-9 Cocoa Fatty Acid should be mixed together prior to adding to the oil phase. Mixing is limited to that required to dissolve the sodium polyacrylate with the oil phase components and then to mix the water and the microbeads for a period of time to create the stable single phase heterogeneous cream and to minimize volatilization of borneol, 1,8-cineole, 1-menthol and d-limonene. Methods of use of the composition of the topical cream given in this Example 12 include but are not meant to be limited to placing the cream composition in a squeeze tube container and placing the cream composition in a hand pump bottle container and applying a quantity of the cream to preferably skin in areas where exposure to poison ivy, oak or sumac has been expected. The cream should be rubbed onto the skin for at least 1 minute and then thoroughly rinsed off with cool water. If exposure to poison ivy, oak or sumac has resulted in Acute Contact Dermatitis (ACD) when treatment with the composition of this Example 12 commenced, the same treatment regime as described above should still be followed. This procedure can be repeated up to 3 times per day for a one day period to insure removal of the urushiol oil from the skin. The topical cream composition in this Example 12 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole, borneol and 1-menthol is shown in FIG. 12. Following removal of the urushiol oil with the formulation disclosed in FIG. 12, treatment to treat reduce ACD symptoms and pruritus can be made with compositions disclosed in Examples 1 through 11 and preferably Example 13. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 13

    [0225] A composition and a method of manufacture of a topical cream, treat ACD and pruritus associated with prior exposure to poison ivy, poison oak or poison sumac comprising: borneol, 1,8-cineole, 1-menthol, sodium hyaluronate and Omega-3 and Omega-9 fatty acids for the composition shown in this Example 13 consists of mixing an amount sodium polyacrylate and poly oxy ethylene (20) sorbitan monolaurate with the oil phase components of the composition to dissolve the sodium polyacrylate then adding an amount of water, such that a stable single phase homogeneous cream results. Prior to the addition of water to the oil phase ingredients the sodium hyaluroate is dissolved in an amount of cold water and mixed until the sodium hyaluronate is completely dissolved in the water. Mixing is limited to that required to dissolve the sodium polyacrylate with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous cream and to minimize volatilization of borneol, 1,8-cineole, 1-menthol. Methods of use of the composition of the topical cream given in this Example 13 to treat dermatitis and pruritus associated with prior exposure to poison ivy, oak and sumac include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The topical cream composition in this Example 13 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole, borneol and 1-menthol is shown in FIG. 13. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    [0226] A combined method of treatment for the exposure to poison ivy, oak or sumac is a two-step process wherein the first step is to remove the urushiol oil with the composition described in Example 12, followed by the treatment of the ACD and pruritus associated with exposure to urushiol oil by the composition described in this Example 13.

    Example 14

    [0227] A composition and a method of manufacture of a topical spray to treat dermatitis and pruritus comprising: borneol, 1-menthol and Omega-3 and Omega-9 fatty acids for the composition shown in this Example 14 consists of mixing isopropyl alcohol with the oil phase components of the composition such that a stable single phase homogeneous liquid results, followed by the addition of an amount of water. Mixing is limited to that required to dissolve alcohol with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous liquid and to minimize volatilization of borneol, 1,8-cineole, and 1-menthol. Methods of use of the composition of the topical liquid spray given in this Example 14 include but are not meant to be limited to sprayable liquid may be applied from a hand-pumped spray bottle or alternatively, or an aerosol from an inert gas pressurized container spray and applying a therapeutic amount of the liquid on the skin or wetting a patch with the liquid placing on the skin. The pressurized container may comprise a single or dual bag-on-valve system to eliminate contact of the liquid with the propellant compressed gas. The topical liquid spray composition in this Example 14 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole, borneol and 1-menthol is shown in FIG. 14. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 15

    [0228] A composition and a method of manufacture of a topical balm to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, 1-menthol and Omega-3 and Omega-9 fatty acids for the composition shown in this Example 15 consists of mixing an amount wax and oils associated with the fatty acid and optionally additional plant oils and plant butters and heating to or slightly above the boiling point of the waxes used. Once the wax and plant oil/butters have melted and a homogeneous melted liquid results, the essential oil compounds can be added while mixing the solution prior to its solidification and a homogeneous solution of the wax, plant oil/butters and essential oils will exist. Mixing is limited to that required to dissolve melted waxes and the plant oils/butters during heating and then when the essential oils are added to the melted wax and plant oils/butters liquid to minimize volatilization of borneol, 1,8-cineole, 1-menthol. Methods of use of the composition of the topical balm given in this Example 15 include but are not meant to be limited to application from ajar, a lip balm tube, an aluminum ointment tube or other types of sealable containers and applying a therapeutic amount of the balm on the skin, lips or wetting a patch with the balm and placing on the skin. The topical balm composition in this Example 15 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole, borneol and 1-menthol is shown in FIG. 15. In addition to treating dermatitis and pruritus, the composition also has fungi static and antibacterial properties.

    Example 16

    [0229] A method of manufacture of a topical cream to treat dermatitis, pruritus and fungal infections comprising: borneol, 1,8-cineole, 1-menthol, a fungi static compound and Omega-3 and Omega-9 fatty acids for the composition shown in Example 16 consists of mixing an amount sodium polyacrylate and polyoxyethylene (20) sorbitan monolaurate with the oil phase components of the composition to dissolve the sodium polyacrylate then adding an amount of a fungistatic compound to the oil phase and mixing sufficiently to dissolve the fungistatic compound in the oil, then adding an amount of water, such that a stable single phase homogeneous cream results. Mixing is limited to that required to dissolve the sodium polyacrylate and the fungistatic compound with the oil phase components and then to mix the water for a period of time to create the stable single phase homogeneous cream and to minimize volatilization of borneol, 1,8-cineole and 1-menthol if it is a volatile compound. Methods of use of the composition of the topical cream given in this Example 16 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The topical cream composition in this Example 16 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole, borneol and 1-menthol is shown in FIG. 16. In addition to treating dermatitis, pruritus and fungal infections, the composition also has antibacterial properties. In addition to the compounds added to the composition shown in FIG. 16, one or more additional antibacterial compounds can be added to increase the antibacterial properties of the cream.

    Example 17

    [0230] A preferred composition and method of manufacture of the topical cream to treat dermatitis, pruritus and fungal infections comprising: borneol, 1,8-cineole, 1-menthol, methyl salicylate, Omega-3 and Omega-9 fatty acids and miconazole nitrate is shown in this Example 17. Manufacturing consists of mixing the oil phase components comprising 20.0 g Thymus satureioides essential oil, 20.0 g Rosmarinus Officinalis Essential Oil, 20.0 g Mentha arvensis essential oil 15.0 g Linum usitatissimum Oil, 15.0 g Prunus armeniaca, 20.00 g Gaultheria procumbens Essential Oil, 20.00 g miconazole nitrate with 7.6 g sodium polyacrylate, 3.8 g poly oxy ethylene (20) sorbitan monolaurate and then mixing sufficiently to dissolve the sodium polyacrylate, followed by then adding 859 g cold water then rapidly mixing for 2 to 5 minutes for the stable single phase homogeneous cream to form. Mixing of the oil phase components with the sodium polyacrylate is limited to that required to dissolve the miconazole nitrate and sodium polyacrylate with the oil phase components. Following this step mixing of the water phase with the oil phase components containing the prior dissolved sodium polyacrylate and the poly oxy ethylene (20) sorbitan monolaurate, is required for a period of time (generally 2 to 5 minutes) to create the stable single phase homogeneous cream and to minimize volatilization of essential oils containing borneol, 1,8-cineole, 1-menthol and methyl salicylate. Methods of use of the composition of the topical cream given in this Example 17 include but are not meant to be limited to placing the cream composition in a roll-on bottle then placing the roll-on ball into the roll-on bottle container, placing the cream composition in a squeeze tube container, placing the cream composition in a hand pump bottle container and applying a therapeutic amount of the cream on the skin or wetting a patch with the cream and placing on the skin. The composition of a topical cream with borneol, 1,8-cineole, 1-menthol, methyl salicylate, miconazole nitrate and Omega-3 and Omega-9 fatty acids is shown in FIG. 17. In addition to treating dermatitis, pruritus, and fungal infections, the composition also has antibacterial properties.

    Example 18

    [0231] A composition and method of manufacture of an orally consumed nutritional supplement to treat dermatitis and pruritus comprising: borneol, 1,8-cineole, and Omega-3 and Omega-9 fatty acids for the composition presented in FIG. 18. The method of manufacture consists of borneol and 1,8-cineole together then mixing Omega-3 and Omega-9 fatty acids. Mixing required in minimal to create a stable single phase homogeneous oil. Methods of use and manufacturing of the composition of the nutritional supplement given in this Example 18 include, but are not meant to be limited to placing 0.5 g to 1.0 g of the mixture gelatin capsules, sealing the capsules with a microspray sealant, heat, or both, or alternatively using pressure. The nutritional supplement composition in this Example 18 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole and borneol presented in FIG. 18. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 19

    [0232] A preferred composition and method of manufacture of the nutritional supplement presented in this Example 19 to treat dermatitis and pruritus comprising: borneol, 1,8-cineole and Omega-3 and Omega-9 fatty acids is presented in FIG. 19. Manufacturing consists of mixing the oil phase components comprising 10.0 g Thymus satureioides 10.0 g Rosmarinus Officinalis Essential Oil, and 980.00 g Fish Oil and then mixing sufficiently to dissolve the ingredients until a single phase homogeneous oil results. Mixing intensity and duration is limited to that required to make a homogeneous oil and to minimize volatilization of essential oils containing borneol and 1,8-cineole. The composition can be placed in an amber glass bottle or various sizes, with and with a dispensing dropper or pump. Alternatively, the composition can be placed into 0.5 g to 1.0 g capsules either manually of automatically in capsules, which are preferably gelatin, then sealed. It is preferable the composition should be refrigerated soon after manufacturing. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties. A person ordinarily skilled in the art would recognize that the fish oil could come from many sources and also could be from crustaceans, including krill. It is important to use the purest fish and crustacean oils to minimize the presence of heavy metals and other impurities, including but not limited to mercury and PCBs. A person ordinarily skilled in the art would also recognize that dependent on the precise composition of the borneol and 1,8-cineole in Thymus satureioides and Rosmarinus Officinalis essential oils used in the formulations that either a greater or smaller amount of the essential oils could be utilized. The nutritional supplement composition in this Example 19 can optionally be made with borneol alone or 1,8-cineole alone same total concentration range as 1,8-cineole and borneol presented in FIG. 19. A person ordinarily skilled in the art would also recognize that the selection of specific fish and krill oil and the method of concentrating EPA and DHA in the oils can vary and can be selected to result in specific EPA and DHA concentrations and to vary the EPA to DHA ratio. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties.

    Example 20

    [0233] A preferred composition and method of manufacture of the nutritional supplement presented in this Example 20 to treat dermatitis and pruritus comprising: borneol, 1,8-cineole and Omega-3 and Omega-9 fatty acids, Vitamin D3, thymoquinone, optionally sodium hyaluronate, and optionally a cannabinoid compound is presented in FIG. 20. Manufacturing consists of mixing the oil phase components comprising 10.0 g Thymus satureioides 10.0 g Rosmarinus Officinalis Essential Oil. 50 g Nigella sativa essential oil and 917.50 g Fish Oil and then slowly mixing 12.5 g cholecalciferol and sufficiently to dissolve the cholecalciferol until a single phase homogeneous oil results. Mixing intensity and duration is limited to that required to dissolved the cholecalciferol and to make a homogeneous oil and to minimize volatilization of essential oils containing borneol and 1,8-cineole. The composition can be placed in an amber glass bottle or various sizes, with and with a dispensing dropper or pump. Alternatively, the composition can be placed into 0.5 g to 1.0 g capsules either manually or automatically in capsules, which are preferably gelatin, then sealed. It is preferable the composition should be refrigerated soon after manufacturing. In addition to treating dermatitis and pruritus, the composition also has fungistatic and antibacterial properties. A person ordinarily skilled in the art would recognize that the fish oil could come from many sources and also could be from crustaceans, including krill. It is important to use the purest fish and crustacean oils to minimize the presence of heavy metals and other impurities, including but not limited to mercury and PCBs. A person ordinarily skilled in the art would also recognize that dependent on the precise composition of the borneol, 1,8-cineole and thymoquinone in Thymus satureioides, Rosmarinus Officinalis and Nigella sativa essential oils used in the formulations that either a greater or smaller amount of the essential oils could be utilized. A person ordinarily skilled in the art would also recognize that the selection of specific fish and krill oil and the method of concentrating EPA and. DHA in the oils can vary and can be selected to result in specific EPA and DHA concentrations and to vary the EPA to DHA ratio. Optionally, sodium hyaluronate or cannabinoid compounds can be added to this composition.

    [0234] While we have shown and described several embodiments in accordance with our disclosure, it is to be clearly understood that the same may be susceptible to numerous changes apparent to one skilled in the art. Therefore, we do not wish to be limited to the details shown and described but intend to show all changes and modifications that come within the scope of the appended claims.