TOPICLEAR - hydroquinone lotion 
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%

Ethylhexyl Methoxycinnamate (Octyl Methoxycinnamate) 0.5%

For external use only

Skin Lightener

Avoid contact with eyes.

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





image of product

TOPICLEAR 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66129-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydroquinone (UNII: XV74C1N1AE) (Hydroquinone - UNII:XV74C1N1AE) Hydroquinone10 mL  in 500 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALLANTOIN (UNII: 344S277G0Z)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHLOROCRESOL (UNII: 36W53O7109)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66129-020-25500 mL in 1 BOTTLE
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: 5/2011
Document Id: 845405e7-dab2-425f-9a87-7e9ec1debb42
Set id: ea2e0dae-24d3-4ab4-be6d-a81644e02fd8
Version: 1
Effective Time: 20110516
 
International Beauty Exchange