1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC119
  



  

  
Submitter : 
  

  
Dr. Donald Rudikoff
  

  
Date & Time: 
  

  
12/07/2006 11:12:14
  



  

  
Organization : 
  

  
Bronx Lebanon Hospital Center
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I am the Chief of Dermatology at Bronx Lebanon Hospital Center and Associate Clinical Professor of Dermatology at the Mount Sinai School of Medicine. I treat a very large number of patients with hydroquinone. I have never in 25 years seen a case of exogenous ochronosis occur in a single patient or for that matter in any case presented in our dermatology conferences. The drug rarely causes irritation and rarely a contact dermatitis.