Label: LUXURY REVITALIZING MOISTURIZING CREAM- glycerin, dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 20151-081-01, 20151-081-02 - Packager: Casmara Cosmetics, SA
- 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 February 21, 2017
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- ACTIVE INGREDIENTS PURPOSE
- USES
- DIRECTIONS
- WARNINGS
- WARNINGS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
water, propylene glycol, butylene glycol dicaprate, ammonium acryloyldimethyltaurate/VP Copolymer, camellia japonica seed oil, betaine, phenoxyethanol, dimethicone crosspolymer, hydrolyzed wheat protein, ascorbic acid, alpha- tocopherol, perflunafene, ethylhexylglycerin, tetrasodium glutamate diacetate, limonene, Vitamina A Palmitate, tert-butyl alcohol, butylated hydroxyloluene, linaool, calcium sulfate, magnesium sulfate, copper sulfate, potassium sulfate, zinc sulfate, manganese sulfate, ferric sulfate
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- Luxury Revitalizing Moisturizing Cream
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INGREDIENTS AND APPEARANCE
LUXURY REVITALIZING MOISTURIZING CREAM
glycerin, dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20151-081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 5 mg in 1 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 4.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) 1417 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg in 1 mL TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg in 1 mL WATER (UNII: 059QF0KO0R) 79.74 mg in 1 mL HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) 0.5 mg in 1 mL DIPROPYLENE GLYCOL (UNII: E107L85C40) 2.5 mg in 1 mL BUTYLENE GLYCOL DICAPRATE (UNII: 3Z317CA098) 2 mg in 1 mL BETAINE (UNII: 3SCV180C9W) 1 mg in 1 mL DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) 0.8 mg in 1 mL ASCORBIC ACID (UNII: PQ6CK8PD0R) 0.33 mg in 1 mL MAGNESIUM SULFATE (UNII: DE08037SAB) 0.00065 mg in 1 mL CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T) 1 mg in 1 mL PERFLUNAFENE (UNII: 54A06VV62N) 0.1 mg in 1 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.03 mg in 1 mL TERT-BUTYL ALCOHOL (UNII: MD83SFE959) 0.03 mg in 1 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.01 mg in 1 mL LINALOOL, (+)- (UNII: F4VNO44C09) 0.006 mg in 1 mL CALCIUM SULFATE (UNII: WAT0DDB505) 0.003 mg in 1 mL BASIC COPPER SULFATE (UNII: CUP529P5NS) 0.0005 mg in 1 mL POTASSIUM SULFATE (UNII: 1K573LC5TV) 0.00025 mg in 1 mL ZINC SULFATE (UNII: 89DS0H96TB) 0.00017 mg in 1 mL MANGANESE SULFATE (UNII: W00LYS4T26) 0.0001 mg in 1 mL FERRIC SULFATE (UNII: 3HWS7HF5XD) 0.00005 mg in 1 mL VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.031 mg in 1 mL .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.134 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20151-081-02 1 in 1 CARTON 02/21/2017 1 NDC:20151-081-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/21/2017 Labeler - Casmara Cosmetics, SA (464973544) Registrant - Casmara Cosmetics, SA (464973544) Establishment Name Address ID/FEI Business Operations Casmara Cosmetics, SA 464973544 manufacture(20151-081)
