DERMACLAIR SKIN LIGHTENING - hydroquinone gel 
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

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

Avoid contact with eyes.

Skin Lightener

For the gradual fading of dark (brownish) areas in the skin such as freckles, age and liver spots

Apply a small amount as a thin layer on the affected area twice daily, or use as directed by a doctor

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

WATER, ALCOHOL, GLYCERIN, CARBOMER COPOLYMER TYPE A, TROLAMINE, SODIUM METABISULFITE, EDETATE DISODIUM

image of product

DERMACLAIR SKIN LIGHTENING 
hydroquinone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66129-134
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66129-134-3150 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: 6/2011
Document Id: dd233d74-59d9-42df-9120-0b9aef99d654
Set id: 391a85f6-544a-4375-b358-ba0cf3d5a84d
Version: 1
Effective Time: 20110629
 
International Beauty Exchange