Label: RENOVATING REGENERATING NOURISHING CREAM- glycerin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 20151-085-01, 20151-085-02 - 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 23, 2017
If you are a consumer or patient please visit this version.
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- WARNINGS
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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- OTHER SAFETY INFORMATION
- Directions
- DOSAGE & ADMINISTRATION
- Uses
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INACTIVE INGREDIENT
Water, Cetyl acetate, Avocado oil, Macadamia integrifolia seed oil, Egg yolk extract, Glyceryl stearate, Sorbitol, Acetylated lanolin, alcohol, Propylene glycol, Triethanolamine, 4-methylbenzylidene camphor, Phenylbenzimidazole sulfonic acid, Phenoxyethanol, Lecithin, Cethyl phosphate, Chestnut seed extract, Carbomer, Corn oil, Glycolic acid, Fragrance, Lactic acid, Ethylhexylglycerin, Tetrasodium glutamate diacetate, Rosa moschata seed oil, Sodium chloride, Caprylyl glycol, BHT, Lysine hydrochloride, Glycinel Arginine, Alanine, Sodium hyaluronate, Mallow extract, Citric acid, Proline, Ascorbyl palmitate, Acetyl hexapeptide-8l Tocopherol, Potassium sorbate, Sodium benzoate, Rosemary leaf extract, Sunflower seed oil, Tricalcium phosphate
- PURPOSE
- Active Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RENOVATING REGENERATING NOURISHING CREAM
glycerin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20151-085 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1.98 mg in 1 mL Inactive Ingredients Ingredient Name Strength SPANISH CHESTNUT (UNII: 2MT5XMR2YW) 0.5 mg in 1 mL ROSA MOSCHATA OIL (UNII: J99W255AWF) 0.062 mg in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.033 mg in 1 mL GLYCOLIC ACID (UNII: 0WT12SX38S) 0.21 mg in 1 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.025 mg in 1 mL LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) 0.022 mg in 1 mL GLYCINE (UNII: TE7660XO1C) 0.022 mg in 1 mL ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.0034 mg in 1 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.0016 mg in 1 mL ROSEMARY (UNII: IJ67X351P9) 0.0012 mg in 1 mL CETYL PHOSPHATE (UNII: VT07D6X67O) 0.75 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.111 mg in 1 mL WATER (UNII: 059QF0KO0R) 58.029 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.94 mg in 1 mL TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.1 mg in 1 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.0025 mg in 1 mL PERFLUNAFENE (UNII: 54A06VV62N) 0.2 mg in 1 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.0016 mg in 1 mL TROLAMINE (UNII: 9O3K93S3TK) 1.6 mg in 1 mL DIPROPYLENE GLYCOL (UNII: E107L85C40) 1.65 mg in 1 mL LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.75 mg in 1 mL TRICALCIUM PHOSPHATE (UNII: K4C08XP666) 0.00011 mg in 1 mL ARGININE (UNII: 94ZLA3W45F) 0.011 mg in 1 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.1 mg in 1 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.008 mg in 1 mL PROLINE (UNII: 9DLQ4CIU6V) 0.0055 mg in 1 mL CETYL ACETATE (UNII: 4Q43814HXS) 11.31 mg in 1 mL AVOCADO OIL (UNII: 6VNO72PFC1) 7 mg in 1 mL SORBITOL (UNII: 506T60A25R) 2 mg in 1 mL MACADAMIA OIL (UNII: 515610SU8C) 4.99 mg in 1 mL ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P) 1.69 mg in 1 mL CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.5 mg in 1 mL ALANINE (UNII: OF5P57N2ZX) 0.011 mg in 1 mL MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5) 0.0099 mg in 1 mL ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) 0.0025 mg in 1 mL CORN OIL (UNII: 8470G57WFM) 0.43 mg in 1 mL SUNFLOWER OIL (UNII: 3W1JG795YI) 0.0012 mg in 1 mL LACTIC ACID (UNII: 33X04XA5AT) 0.18 mg in 1 mL GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 2.4 mg in 1 mL EGG YOLK (UNII: 4IPS17B70T) 2.4 mg in 1 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.022 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20151-085-02 1 in 1 BOTTLE, DISPENSING 02/23/2017 1 NDC:20151-085-01 50 mL in 1 BOTTLE, DISPENSING; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/12/2016 Labeler - Casmara Cosmetics, SA (464973544) Registrant - Casmara Cosmetics, SA (464973544) Establishment Name Address ID/FEI Business Operations Casmara Cosmetics, SA 464973544 manufacture(20151-085)
