Label: OMIJA WHITENING- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-007-01 - Packager: SKINFOOD CO., LTD.
- 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 22, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
WATER, SCHIZANDRA CHINENSIS FRUIT EXTRACT, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, BIOSACCHARIDE GUM-1, PEG-10 DIMETHICONE, NIACINAMIDE, ISOTRIDECYL ISONONANOATE, SODIUM CHLORIDE, LACTOBACILLUS FERMENT LYSATE FILTRATE, SALIX NIGRA (WILLOW) BARK EXTRACT, SODIUM HYALURONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIACETYL BOLDINE, MAACKIA FAURIEI STEM EXTRACT, POLYSILICONE-11, SODIUM CITRATE, TOCOPHERYL ACETATE, SORBITOL, PROPYLENE GLYCOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, DISODIUM EDTA, CITRIC ACID, HYDROGENATED LECITHIN, SUCROSE LAURATE, ASCORBYL TETRAISOPALMITATE, ALCOHOL DENAT., MORUS ALBA ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, LYSOLECITHIN, CERAMIDE 3, SODIUM ASCORBYL PHOSPHATE, METHYLPARABEN, PHENOXYETHANOL, FRAGRANCE
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OMIJA WHITENING
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-007 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) NIACINAMIDE (UNII: 25X51I8RD4) ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT) SODIUM CHLORIDE (UNII: 451W47IQ8X) SALIX NIGRA BARK (UNII: QU52J3A5B3) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) MAACKIA FLORIBUNDA STEM (UNII: 84UXW52K8Y) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CHAMOMILE (UNII: FGL3685T2X) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SUCROSE LAURATE (UNII: 05Q7CD0E49) MORUS ALBA ROOT (UNII: CST1G9BZGD) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CERAMIDE 3 (UNII: 4370DF050B) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-007-01 50 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2011 Labeler - SKINFOOD CO., LTD. (690324173) Registrant - SKINFOOD CO., LTD. (690324173) Establishment Name Address ID/FEI Business Operations SKINFOOD CO., LTD. 690324173 manufacture