Label: GRAIN VITA FERMENTED- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL

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 April 18, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Polysorbate 60, Beeswax, Cetearyl Alcohol, Glyceryl Stearate SE, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Sorbitan Sesquioleate, Betula Alba Juice, Betaine, Copernicia Cerifera (Carnauba) Wax, Adenosine, Saccharomyces/Rice Bran Ferment, Tocopheryl Acetate, Oryza Sativa (Rice) Extract, Sesamum Indicum (Sesame) Seed Extract, Perilla Ocymoides Seed Extract, Phaseolus Radiatus Seed Extract, Triticum Turgidum Durum (Wheat) Seed Extract, Phaseolus Angularis Seed Extract, Glycine Max (Soybean) Seed Extract, Pinus Koraiensis Seed Extract, Glycine Max (Soybean) Seed Extract, Juglans Regia (Walnut) Seed Extract, Arachis Hypogaea (Peanut) Fruit Extract, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Sesamum Indicum (Sesame) Seed Extract, Polygonum Fagopyrum (Buckwheat) Seed Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Hordeum Distichon (Barley) Extract, Helianthus Annuus (Sunflower) Seed Extract, Avena Sativa (Oat) Meal Extract, Rosa Canina Seed Extract, Ginkgo Biloba Nut Extract, Honey Extract, Wild Ginseng Root Culture Extract, Chrysanthemum Morifolium Flower Extract, Citrus Unshiu Fruit Extract, Oenothera Biennis (Evening Primrose) Oil, Phellodendron Amurense Bark Extract, Coptis Chinensis Root Extract, Scutellaria Baicalensis Root Extract, Rhus Semialata Gall Extract, Silkworm Extract, Allantoin, 1,2-Hexanediol, Carbomer, Disodium EDTA, Triethanolamine, Phenoxyethanol, Fragrance

  • PURPOSE

    Purpose: Anti-wrinkle

    Compounding the substances from Saccharomyces/Rice Bran Ferment and Tocopheryl Acetate, vitamin E derivative, on the base of grain extracts make the skin comfortable, it firmly protects the moisture to smooth the skin and gives the anti-wrinkle function. Grain based moisturizing ingredients. Skin conditioning component ( vitamin E derivative ) compounding. Firmly to protect the moisture of skin , to smooth skin. Anti-wrinkle functional cream.

  • WARNINGS

    Warnings: 1. If the following symptoms arise upon use of the cosmetic product, immediately discontinue use and consult a dermatologist, for continued use may aggravate the symptoms. A. Redness, swelling, itchiness, stimulation, or other symptoms B. Occurrence of the above symptoms upon exposure to direct sunlight. 2. Do not use on areas with wounds, eczema, or dermatitis. 3. Do not store in areas with extreme heat or cold, or under direct sunlight. 4. Avoid the eye area 5. Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: Softly apply cream along the skin texture and pat gently for better absorption. 1. Put size of a nickel on the palm and apply to entire face and neck evenly. 2. Apply to the face outwards and neck from tap-down.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    GRAIN VITA FERMENTED 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70567-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.0 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70567-040-0150 mL in 1 CARTON; Type 0: Not a Combination Product03/02/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/02/2016
    Labeler - KHLEEKOREA (631081312)
    Registrant - KHLEEKOREA (631081312)
    Establishment
    NameAddressID/FEIBusiness Operations
    KHLEEKOREA631081312manufacture(70567-040)