Label: UNIWELL NATURAL- niacinamide, adenosine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 14, 2017

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  • ACTIVE INGREDIENT

    NIACINAMIDE 2.00%

    ADENOSINE 0.04%

  • PURPOSE

    Brighting and Wrinkle Care

  • INDICATIONS & USAGE

    skin brightening
    wrinkle care

  • DOSAGE & ADMINISTRATION

    Apply a proper amount around affected area in the morning and evening.

  • WARNINGS

    For external use only.
    Do not use on damaged or broken skin.
    When using this product, keep out of eyes. Rinse with water to remove.
    Stop using and ask a doctor if rash occurs.

  • 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, Glycerin, Propanediol, Cetyl Ethylhexanoate, Squalane, Vitis Vinifera (Grape) Seed Oil, C14-22 Alcohols, 1,2-Hexanediol, Beeswax, Dimethicone, Cetearyl Alcohol, C12-20 Alkyl Glucoside, Polyacrylate-13, Arginine, Carbomer, Panthenol, Tocopheryl Acetate, Polyisobutene, Citrus Aurantium Dulcis (Orange) Oil, Polysorbate 20, Sorbitan Isostearate, Butylene Glycol, Phenoxyethanol, Beta-Glucan, Theobroma Cacao (Cocoa) Extract, 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, Dextrin, Alcohol, Ethylhexylglycerin, Sodium Hyaluronate, Disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    UNIWELL NATURAL 
    niacinamide, adenosine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71502-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE1 mg  in 50 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.02 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARGININE (UNII: 94ZLA3W45F)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    SQUALANE (UNII: GW89575KF9)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCOA (UNII: D9108TZ9KG)  
    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)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71502-003-021 in 1 PACKAGE06/13/2017
    1NDC:71502-003-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/13/2017
    Labeler - uniwell LTD (694646565)
    Registrant - uniwell LTD (694646565)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(71502-003)