UNIWELL NATURAL ESSENCE (DIMETHICONE) EMULSION [UNIWELL LTD]

UNIWELL NATURAL ESSENCE (DIMETHICONE) EMULSION [UNIWELL LTD]
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NDC 71502-002-01, 71502-002-02
Set ID 5d4d3fc1-1172-4193-bac2-ff97d8132488
Category HUMAN OTC DRUG LABEL
Packager uniwell LTD
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    DIMETHICONE 1.875%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Helps prevent and temporarily protects chafed, chapped or cracked skin.
    Helps prevent and protect from the drying effects of wind and cold weather.


  • DOSAGE & ADMINISTRATION

    Apply as needed.

  • WARNINGS

    For external use only.
    Do not use on deep or puncture wounds, animal bites, or serious burns.
    Stop use and ask a doctor if condition worsen, symptoms last more than 7 days or clean up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    UNIWELL NATURAL ESSENCE 
    dimethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71502-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.937 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71502-002-021 in 1 PACKAGE06/12/2017
    1NDC:71502-002-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/12/2017
    Labeler - uniwell LTD (694646565)
    Registrant - uniwell LTD (694646565)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(71502-002)

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