1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC128
  



  

  
Submitter : 
  

  
Dr. Wieke Liem
  

  
Date & Time: 
  

  
12/07/2006 11:12:32
  



  

  
Organization : 
  

  
Dr. Wieke Liem
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Hydroquinone is one of the most effective agents in treating hyperpigmentation, used over 50 yrs in millions of people.  It is used to treat melasma, psot-inflammatory hyperpigmentation, and medically and cosmetically disfiguring dyschromias.

Since 1961, hydroquinone has a very safe and effective treatment profile.  In spite of human exposure to natural sources of hydroquinone in wheat, pears, berries, coffee, tea, onions, rice and red wine, there is not an association with carcinogenicity.  There have been no reported cases of related cancers in more than 50 yrs of use of hydroquinone.