1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC117
Submitter : Dr. thomas smith Date & Time: 12/07/2006 11:12:55
Organization : associates in dermatology
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a Dermatologist in practice for 35 years, I have prescribed topical hydroquinone for 5,000-6,000 patients. I have seen not one case of ochronosis in those patients. I have never prescribed it for patients who simply want their skin to be a lighter tone, but always for disfiguring hyperpigmentation- almost always melasma. I would not object to closer regulation of OTC hydroquinone products to make sure that manufacturers are not increasing the concentration to more than the presently allowed 2%, but I strenuously object to attempts to interfere with by- prescription-only use of 4% hydroquinone. I challenge you to publicize any case where a patient has been harmed by either a brand-name or generic prescription hydroquinone.