Label: PIBUBAB GRAIN TOTAL WRINKLE BRAKE- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70567-030-01 - Packager: KHLEEKOREA
- 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 April 18, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Petrolatum, Polysorbate 60, Beeswax, Stearic Acid, Glyceryl Stearate/PEG-100 Stearate, Cetearyl Alcohol, Glyceryl Stearate SE, Sorbitan Sesquioleate, 1,2-Hexanediol, Phenoxyethanol, Carbomer, Tiethanolamine, Allantoin, Adenosine, Xanthan Gum, 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, Fragrance
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PURPOSE
Purpose: Skin Anti-wrinkle
As botanical extracts from 20 grains supplies the skin abundant nutrition, the skin becomes smoother, moisturized and looks radiant. A combination of active substances from grains intensively gives the skin complete revitalisation and ant-wrinkle functional effects around the eyes, mouth and/or of the neck. Anti-wrinkle functional cosmetic product.
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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
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PIBUBAB GRAIN TOTAL WRINKLE BRAKE
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70567-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 1.0 g in 20 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70567-030-01 20 mL in 1 CARTON; Type 0: Not a Combination Product 03/02/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/02/2016 Labeler - KHLEEKOREA (631081312) Registrant - KHLEEKOREA (631081312) Establishment Name Address ID/FEI Business Operations KHLEEKOREA 631081312 manufacture(70567-030)
