AFRICAN FORMULA BLACK - hydroquinone cream 
International Beauty Exchange

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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Drug Facts

Hydroquinone 2%

For external use only

Skin Lightener

On children under 12 years of age unless directed by a doctor

Avoid contact with eyes.

If swallowed, get medical help or contact a Poison Control Center right away.




image of product

AFRICAN FORMULA BLACK 
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66129-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE1 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66129-102-3150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A01/01/2011
Labeler - International Beauty Exchange (966261273)
Establishment
NameAddressID/FEIBusiness Operations
JABONES PARDO SA462018250manufacture

Revised: 3/2011
Document Id: e7d9b1c6-baf0-4f26-85de-16ea23283ebd
Set id: b7b897f5-37ea-4f4d-9247-e1226c0c1217
Version: 1
Effective Time: 20110329
 
International Beauty Exchange