1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC137
  



  

  
Submitter : 
  

  
Dr. Melissa Rubenstein
  

  
Date & Time: 
  

  
12/11/2006 09:12:36
  



  

  
Organization : 
  

  
Dr. Melissa Rubenstein
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
   It would be a huge loss to lose hydroquinone from the market.  It is the only reasonably good treatment for patients with hyperpigmentation.  I use it in my practice very often and patients definitely benefit from the treatment. 

  Hydroquinone is one of the most effective molecules for the treatment of dark discoloration over the past 40-50 years and has been used in millions of people. It is used to treat the top concerns among 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 There have been no reported cases of related malignancies in more than 50 years of manufacture and use of HQ.

  Please do not take hydroquinone off the market.