DARK SPOT LIGHTENING CREAM- hydroquinone cream 
Cosmetic Enterprises Ltd.

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.

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Dark Spot Lightening Cream

Active ingredient Purpose

Hydroquinone 2% Skin lightener

Use

Lightens dark (brownish) discolorations in the skin such as: freckles, age and liver spots or pigment in the skin that may occur in pregnancy or from the use of oral contraceptives

Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

Warnings

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

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.

Directions

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

Dark Spot Lightening Cream

2% Hydroquinone

6% Glycolic Acid

1.7 FL OZ 50mL

box

label

DARK SPOT LIGHTENING CREAM 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56152-4002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56152-4002-150 mL in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A12/21/2018
Labeler - Cosmetic Enterprises Ltd. (017701475)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd.217269489manufacture(56152-4002)

Revised: 12/2018
Document Id: 7d8d68c1-a16c-29d3-e053-2991aa0a0563
Set id: 7d8d68c1-a16b-29d3-e053-2991aa0a0563
Version: 1
Effective Time: 20181221
 
Cosmetic Enterprises Ltd.