Label: DIVINE DERRIER SKIN BLEACHING CREAM- hydroquinone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 56152-4004-1 - Packager: Cosmetic Enterprises Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 7, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings: for external use only
When using this product
- Avoid contact with eyes
- Limit sun exposure. Protect skin with a Broad-Spectrum sunscreen agent, wear protective clothing to cover bleached skin after treatment to prevent darkening from reoccuring
- Some users of this product may experience mild irritation. If skin irritation becomes severe, stop use and consult a physician
- Do not use on children under 12 years of age unless directed by a physician
- If product consult with a doctor before use
- If pregnant or breast-feeding
- Speak with a healthcare professional before use
Sunburn alert
- This product contains an alpha-hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
Inactive Ingredients Water(Aqua), Isopropyl Palmitate, Caprylic/capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, Propanediol, Glycolic Acid, Lactic Acid, Kojic Dipalmitate, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Niacinamide, Allantoin, Ferulic Acid, Butylene Glycol, hydrogenated Lecithin, Sodium Oleate, Oligopeptide-68, Dipotassium Glycrrhizate, Sodium Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Dimethicone, PEG-40 Stearate, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Phenoxyethanol, Frangrance.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DIVINE DERRIER SKIN BLEACHING CREAM
hydroquinone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-4004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPANEDIOL (UNII: 5965N8W85T) GLYCOLIC ACID (UNII: 0WT12SX38S) NIACINAMIDE (UNII: 25X51I8RD4) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) FERULIC ACID (UNII: AVM951ZWST) SODIUM OLEATE (UNII: 399SL044HN) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PEG-40 STEARATE (UNII: ECU18C66Q7) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) KOJIC DIPALMITATE (UNII: 13N249RWTM) SODIUM HYDROXIDE (UNII: 55X04QC32I) LACTIC ACID (UNII: 33X04XA5AT) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM SULFATE (UNII: 0YPR65R21J) SODIUM METABISULFITE (UNII: 4VON5FNS3C) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-4004-1 50 mL in 1 JAR; Type 0: Not a Combination Product 01/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 01/10/2019 Labeler - Cosmetic Enterprises Ltd (017701475) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises Ltd 017701475 manufacture(56152-4004)
