Label: PRESTIGE JEJU SNAIL EYE- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 29, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 10.18%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Snail Secretion Filtrate, Dipropylene Glycol, Cyclopentasiloxane, Butylene Glycol, Glycerin, Niacinamide, Silica, Trisiloxane, Cetearyl Alcohol, 1,2-Hexanediol, Dicaprylyl Carbonate, Cetearyl Olivate, Sorbitan Olivate, Glyceryl Stearate, PEG-100 Stearate, PCA Dimethicone, PEG-150 Distearate, C14-22 Alcohols, Phenoxyethanol, Stearic Acid, Ammonium Acryloyldimethyltaurate/VP Copolymer, Panthenol, Dimethiconol, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Caprylyl Glycol, C12-20 Alkyl Glucoside, Water, Dimethicone Crosspolymer, PEG-2M, Adenosine, Citrus Limon (Lemon) Peel Oil, Hydrogenated Lecithin, Dipotassium Glycyrrhizate, Citrus Aurantium Dulcis (Orange) Oil, Sucrose Distearate, Ethylhexylglycerin, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Centella Asiatica Extract, Olea Europaea (Olive) Fruit Oil, Opuntia Coccinellifera Fruit Extract, Pinus Sylvestris Leaf Oil, Ficus Carica (Fig) Fruit Extract, Gardenia Florida Fruit Extract, Salvia Sclarea (Clary) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Gold (CI 77480), Eucalyptus Globulus Leaf Oil, Camellia Japonica Flower Extract, Cinnamomum Camphora (Camphor) Leaf Extract, Camellia Sinensis Leaf Extract, Citrus Unshiu Peel Extract, sh-Octapeptide-4, sh-Decapeptide-7, rh-Oligopeptide-1, rh-Polypeptide-1, rh-Oligopeptide-2, rh-Polypeptide-3, 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 EYE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-317
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone3.05 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Dipropylene Glycol (UNII: E107L85C40)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-317-021 in 1 CARTON07/01/2016
    1NDC:59078-317-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/01/2016
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-317)