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Name:African Formula Black
Manufacturer:International Beauty Exchange
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:66129-102
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 1 g  in 50 g
Inactive Ingredients
Ingredient Name Strength
WATER  
ALCOHOL  
GLYCERIN  
CARBOMER COPOLYMER TYPE A  
COCOA BUTTER  
.ALPHA.-TOCOPHEROL ACETATE, D-  
ASCORBIC ACID  
SODIUM METABISULFITE  
EDETATE DISODIUM  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66129-102-31 50 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358A 01/01/2011

Labeler - International Beauty Exchange (966261273)
Establishment
Name Address ID/FEI Operations
JABONES PARDO SA 462018250 manufacture

Revised: 03/2011 International Beauty Exchange



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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