Label: PRESTIGE JEJU SNAIL- glycerin, niacinamide emulsion

  • 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: Glycerin 8.98%, Niacinamide 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Snail Secretion Filtrate, Water, Hydrogenated Polydecene, Cetyl Ethylhexanoate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cyclopentasiloxane, Macadamia Ternifolia Seed Oil, Cetearyl Alcohol, Hydrogenated Vegetable Oil, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Cyclohexasiloxane, Betaine, Palmitic Acid, Carbomer, Polyacrylate-13, Stearic Acid, Tromethamine, Phenoxyethanol, Dimethicone, Tocopheryl Acetate, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Caprylyl Glycol, Xanthan Gum, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Polysorbate 20, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Sorbitan Isostearate, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Rosa Canina Fruit Oil, Citrus aurantium dulcis (orange) peel oil, Citrus Aurantifolia (Lime) Oil, Camellia Japonica Flower Extract, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Gold, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Gardenia Jasminoides Fruit Extract, Opuntia Coccinellifera Fruit Extract, Citric Acid, 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 
    glycerin, niacinamide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin11.22 g  in 125 mL
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.50 g  in 125 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-318-021 in 1 CARTON07/01/2016
    1NDC:59078-318-01125 mL in 1 BOTTLE, PUMP; 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(59078-318)
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