Label: PRESTIGE JEJU SNAIL ESSENCE- glycerin, niacinamide 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: Glycerin 5.52%, Niacinamide 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Snail Secretion Filtrate, Propanediol, Alcohol Denat., Water, Cyclopentasiloxane, Tromethamine, Bis-PEG-18 Methyl Ether Dimethyl Silane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Cetyl Ethylhexanoate, Hydrogenated Vegetable Oil, Stearic Acid, Phenoxyethanol, Chlorphenesin, Vegetable Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Caprylyl Glycol, Dimethicone, Alcohol, Phenyl Trimethicone, Citrus Limon (Lemon) Peel Oil, Adenosine, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Sodium Hyaluronate, Citrus aurantium dulcis (orange) peel oil, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Gold, Butylene Glycol, Camellia Japonica Flower Extract, Citrus Unshiu Fruit Extract, Dipropylene Glycol, 1,2-Hexanediol, Pentylene Glycol, Camellia Sinensis Leaf Extract, Ficus Carica (Fig) Fruit Extract, Centella Asiatica 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 ESSENCE 
    glycerin, niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin2.76 g  in 50 mL
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide1.0 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propanediol (UNII: 5965N8W85T)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-319-021 in 1 CARTON07/01/2016
    1NDC:59078-319-0150 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(59078-319)
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