PIGMENT- hydroquinone gel 
G.S. COSMECEUTICAL USA, INC.

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

Principal Display Panel - 29.5 mL Label
PIGMENT 
hydroquinone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-9003
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
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LACTIC ACID (UNII: 33X04XA5AT)  
AZELAIC ACID (UNII: F2VW3D43YT)  
KOJIC ACID (UNII: 6K23F1TT52)  
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: S38J6RZN16)  
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
GLUTATHIONE (UNII: GAN16C9B8O)  
SILYBUM MARIANUM SEED (UNII: U946SH95EE)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE

Revised: 11/2011
Document Id: ea696aa1-3521-420f-95ec-78e215c1abbc
Set id: b0bf5462-bd6f-4233-aa03-344532f94271
Version: 1
Effective Time: 20111115
 
G.S. COSMECEUTICAL USA, INC.