1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC112
  



  

  
Submitter : 
  

  
Dr. Melissa Camouse
  

  
Date & Time: 
  

  
12/07/2006 11:12:02
  



  

  
Organization : 
  

  
Dr. Melissa Camouse
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 As a physician it is a tragedy to see safe and efficacious medications that make a profound impact on patients' disease states become unavailable. Hydroquinone is one of the most effective agents for the treatment of skin discoloration over the past 40-50 years and has been used safely in millions of people. It is used to treat the daily concerns of our patients including melasma, photo-aging, post-inflammatory hyperpigmentation, medically and cosmetic disfiguring dyschromias. 

Since 1961, hydroquinone has demonstrated a safe and effect profile among clinicians prescribing or recommending hydroquinone products. In spite of humans 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 malignancies in more than 50 years of use of HQ.