GRAIN VITA FERMENTED- dimethicone cream 
KHLEEKOREA

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.

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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

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)

Revised: 4/2016
Document Id: f9b118bf-ab59-4679-852e-d85b4cfe419f
Set id: 39201995-8e22-4e82-8a61-84536d4ba26d
Version: 1
Effective Time: 20160418
 
KHLEEKOREA