1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC180
  



  

  
Submitter : 
  

  
Dr. Ronald Buckley
  

  
Date & Time: 
  

  
12/20/2006 08:12:59
  



  

  
Organization : 
  

  
Lakeview Medical Center
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 My name is Dr. Ronald Buckley.  I practice dermatology in private practice for the past 7.5 years and as a military physician for 10 years.  This letter is in support of allowing hydroquinone to remain on the market as a safe bleaching cream for the hundreds of patients that I have either written a prescription for or recommended its purchase over the counter.  



In my clinical experience, I have not encountered a patient with exogenous ochronosis nor any evidence of malignancies. Hydroquinone remains one of the most effective molecules for the treatment of dark discoloration.  I have used it to treat the top concerns among my patients including melasma, photo-aging, post-inflammatory hyperpigmentation, medically and cosmetic disfiguring dyschromias.



Since the 1960's, hydroquinone has demonstrated a safe and effect profile among physicians 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 manufacture and use of hydroquinone.

Thank you for you time.



Ronald Buckley, D.O.