Label: TONYMOLY INTENSE CARE GOLD 24K SNAIL- 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 June 25, 2014

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 1%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Snail Secretion Filtrate, Butylene Glycol, Glycerin, Propanediol, Glycereth-26, Niacinamide, Methyl Gluceth-20, Cetyl Ethylhexanoate, Cyclopentasiloxane, Water, Polysorbate 60, Hydrogenated Polydecene, Glyceryl Stearate, Microcrystalline Wax, Cyclohexasiloxane, Carbomer, PEG-100 Stearate, Tromethamine, Ceresin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Chlorphenesin, Caprylyl Glycol, Ethylhexylglycerin, Dimethicone, Glyceryl Polyacrylate, Citrus Medica Limonum (Lemon) Peel Oil, Citrus Unshiu Fruit Extract, Adenosine, Titanium Dioxide (CI 77891), Panax Ginseng Callus Culture Extract, Viscum Album (Mistletoe) Extract, Sasa Quelpaertensis Extract, Nelumbo Nucifera Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Mica (CI 77019), Morus Bombycis Leaf Extract, Volcanic Ash, Citrus aurantium dulcis (orange) peel oil, Artemisia Vulgaris Extract, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, 1,2-Hexanediol, Gold, Iron Oxides, Eucalyptus Globulus Leaf Oil, Aureobasidium Pullulans Ferment, Xanthan Gum, Opuntia Coccinellifera Fruit Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Lecithin, Usnea Barbata (Lichen) Extract, Sodium Hyaluronate, Glycine Soja (Soybean) Oil, Sodium Ascorbyl Phosphate, Acetyl Heptapeptide-9, Colloidal Gold, rh-Oligopeptide-1

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warning:
    1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
    1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
    2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
    2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
    3. In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children

  • INDICATIONS AND USAGE

    Indications and usage:
    Take one pearl size amount on cheeks, forehead and chin and spread following the skin texture.
    Tap lightly for better absorption.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TONYMOLY INTENSE CARE GOLD 24K SNAIL 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.45 mg  in 45 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-045-0145 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2014
    Labeler - TONYMOLY CO., LTD. (688216798)
    Registrant - TONYMOLY CO., LTD. (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO., LTD.688216798manufacture(59078-045)