Label: DARK SPOT LIGHTENING CREAM- hydroquinone cream
- 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.
Updated December 21, 2018
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
For external use only
Allergy alert: contains sulfites that may cause serious allergic type reactions such as hives, itching, wheezing as severe asthma attack in certain susceptible persons.
Do not use on children under 12 years of age unless directed by a doctor
When using this product
- avoid contact with eyes
- some users may experience a mild skin irritatiion\
Sunburn alert: This product 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.
If pregnant or breast-feeding, ask a doctor before use.
DOSAGE & ADMINISTRATION
- Adults: apply a small amount as a thin layer on the affected area in the evening, or use as directed by a doctor. If no improvement is seen in 3 months of treatment, use of this product should be discontinued. Lightening effect of this product might not be noticeable when used on very dark skin.
- Children under 12 years of age: do not use unless directed by a doctor.
- Sun Exposure should be limited by using a sunscreen agent, a sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
Water (Aqua), Glycolic Acid, Glyceryl Stearate, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Propanediol, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Phenoxyethanol, Sodium Sulfate, Sodium Metabisulfite, Tocopheryl Acetate, Dimethicone, PEG-40 Stearate, Disodium EDTA, Xantan Gum, Allantoin, Ferulic Acid, Ethylhexylglycerin, Dipotassium Glycyrrhizate
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DARK SPOT LIGHTENING CREAM
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-4002 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PROPANEDIOL (UNII: 5965N8W85T) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) SODIUM SULFATE (UNII: 0YPR65R21J) SODIUM METABISULFITE (UNII: 4VON5FNS3C) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-40 STEARATE (UNII: ECU18C66Q7) FERULIC ACID (UNII: AVM951ZWST) ALLANTOIN, (+)- (UNII: XDK458E1J9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) WATER (UNII: 059QF0KO0R) GLYCOLIC ACID (UNII: 0WT12SX38S) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-4002-1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part358A 12/21/2018 Labeler - Cosmetic Enterprises Ltd. (017701475) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises Ltd. 217269489 manufacture(56152-4002)