PIGMENT

Dosage form: gel
Ingredients: HYDROQUINONE 2g in 100mL
Labeler: G.S. COSMECEUTICAL USA, INC.
NDC Code: 65113-9003

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.

pigment gel®

PRINCIPAL DISPLAY PANEL - 29.5 mL Label

pigment gel®

PCA skin®

1 fl oz/1 oz liq/29.5 mL

PIGMENT 
hydroquinone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-9003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
WATER 
HAMAMELIS VIRGINIANA LEAF WATER 
BUTYLENE GLYCOL 
LACTIC ACID 
AZELAIC ACID 
KOJIC ACID 
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION) 
PHENYLETHYL RESORCINOL 
GLUTATHIONE 
SILYBUM MARIANUM SEED 
BUTYLATED HYDROXYTOLUENE 
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65113-9003-17.4 mL in 1 BOTTLE, PLASTIC
2NDC:65113-9003-229.5 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR05/26/2011
Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)
Establishment
NameAddressID/FEIOperations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE

Revised: 11/2011
 
G.S. COSMECEUTICAL USA, INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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