Label: PRESTIGE JEJU SNAIL- niacinamide, dimethicone cream

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

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Drug Label Information

Updated July 29, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Niacinamide 2.0%, Dimethicone 0.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Snail Secretion Filtrate, Macadamia Ternifolia Seed Oil, Hydrogenated Polydecene, Water, Cetearyl Alcohol, Cetyl Ethylhexanoate, Glycol Stearate SE, Panthenol, Caprylic/Capric Triglyceride, Octyldodecyl Myristate, Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Glyceryl Stearate, Beeswax, Sodium Polyacrylate, PEG-100 Stearate, Cyclopentasiloxane, Ethylhexyl Stearate, Glycerin, Palmitic Acid, Stearic Acid, Hydrogenated Lecithin, Phenoxyethanol, Chlorphenesin, Propanediol, Ethylhexylglycerin, Tocopheryl Acetate, Caprylyl Glycol, Dimethiconol, Laureth-23, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Trideceth-6, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Alcohol, Citrus aurantium dulcis (orange) peel oil, Beta-Glucan, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Sodium Hyaluronate, Eucalyptus Globulus Leaf Oil, Gold, Butylene Glycol, Camellia Japonica Flower Extract, Citric Acid, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Gardenia Jasminoides Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Opuntia Coccinellifera Fruit Extract, rh-Polypeptide-22

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Use

    Use: Helps prevent and relieve chapped or cracked skin

  • Directions

    Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PRESTIGE JEJU SNAIL 
    niacinamide, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.90 g  in 45 mL
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.22 g  in 45 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Panthenol (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-316-021 in 1 CARTON07/01/2016
    1NDC:59078-316-0145 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2016
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-316)
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