1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC330
  



  

  
Submitter : 
  

  
Ms. Patricia Price
  

  
Date & Time: 
  

  
12/21/2006 09:12:42
  



  

  
Organization : 
  

  
Ms. Patricia Price
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dear Sir or Madam:

I have topically used Obagi products, which contain hydroquinone, for the past 4 years.  They have dramatically improved the condition of my skin and were essential to the care of my complexion during my recent deployment in the harsh climate of Iraq.  I have never experienced negative effects, only positive ones, and strongly object to the removal of this product from the market.  The plastic surgery aestetician who recommended Obagi informed me that it had not yet been approved for pregnant women.  If your results from your lab tests conclusively show that it is contraindicated for pregnant women to apply topically, could you not issue a warning and insist that the manufacturers include this on the packaging of their products instead of removing it from the market completely?  There are numerous products, to include several medications for erectile dysfunction, which the FDA has indicated may cause birth defects and should not be handled or ingested by pregnant women or those desiring to become pregnant.  These products are allowed to remain on the market as long as the warnings are made available to consumers.  Please consider doing the same with products containing hydroquinone.



Sincerely,

Patricia Price