Label: UNIWELL NATURAL ESSENCE- dimethicone emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 71502-002-01, 71502-002-02 - Packager: uniwell LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 12, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Butylene Glycol, Glycerin, 1,2-Hexanediol, Niacinamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Arginine, Carbomer, Propanediol, Polyacrylate-13, Hydroxyacetophenone, Polyisobutene, Citrus Aurantium Dulcis (Orange) Oil, Allantoin, Dipotassium Glycyrrhizate, Adenosine, Ethylhexylglycerin, Polysorbate 20, Phenoxyethanol, Theobroma Cacao (Cocoa) Extract, Sorbitan Isostearate, Disodium EDTA, Beta-Glucan, Dextrin, Ecklonia cava Extract, Glycine Soja (Soybean) Sprout Extract, Triticum Vulgare (Wheat) Sprout Extract, Brassica Oleracea Italica (Broccoli) Sprout Extract, Camellia Oleifera Leaf Extract, Magnolia Liliflora Flower Extract, Eugenia Caryophyllus (Clove) Bud Extract, Sophora Japonica Flower Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Alcohol, Phenoxyethanol, Sodium Hyaluronate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UNIWELL NATURAL ESSENCE
dimethicone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71502-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.937 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Glycerin (UNII: PDC6A3C0OX) 1,2-Hexanediol (UNII: TR046Y3K1G) NIACINAMIDE (UNII: 25X51I8RD4) Squalane (UNII: GW89575KF9) Arginine (UNII: 94ZLA3W45F) Propanediol (UNII: 5965N8W85T) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) 2-HYDROXYACETOPHENONE (UNII: DQ1N9R01IA) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) ORANGE OIL (UNII: AKN3KSD11B) Allantoin (UNII: 344S277G0Z) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) Adenosine (UNII: K72T3FS567) Ethylhexylglycerin (UNII: 147D247K3P) Polysorbate 20 (UNII: 7T1F30V5YH) COCOA (UNII: D9108TZ9KG) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ECKLONIA CAVA (UNII: UXX2N5V39P) SOYBEAN (UNII: L7HT8F1ZOD) WHEAT SPROUT (UNII: 3K32950CI0) BROCCOLI SPROUT (UNII: 128UH9LOAE) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) MAGNOLIA LILIIFLORA FLOWER (UNII: SVM28292LH) CLOVE (UNII: K48IKT5321) STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E) LAVENDER OIL (UNII: ZBP1YXW0H8) LEMON OIL (UNII: I9GRO824LL) ALCOHOL (UNII: 3K9958V90M) Phenoxyethanol (UNII: HIE492ZZ3T) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71502-002-02 1 in 1 PACKAGE 06/12/2017 1 NDC:71502-002-01 50 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/12/2017 Labeler - uniwell LTD (694646565) Registrant - uniwell LTD (694646565) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71502-002)
