1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC108
Submitter : Dr. Julie Voss Date & Time: 12/07/2006 11:12:16
Organization : Dr. Julie Voss
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a dermatologist that has used Hydroquinone products for 12 years on countless patients. I have seen one case of hydroquinone caused ochronosis and that was a patient from Africa where they can get 8% hydroquinone over the counter. Her ochronosis was easily treated with topical retinoids. Basically, Hydroquinone is a very safe product at the concentrations available in this country and I have never had any trouble with the product, except some mild irritation. It would be a great disservice to decrease the availability of this product to the consumer.
Sincerely,
Julie E. Voss, M.D.