1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC125
Submitter : Dr. Anne Laumann Date & Time: 12/07/2006 11:12:01
Organization : Northwestern University, Chicago
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am at a loss about this proposal. I have used topical hydroquinone therapy for hyperpigmentation for my many dark skinned patients for over twenty five years. This agent at the marketed percentages of 2% OTC and 2% - 4% on prescription has proven very safe and effective. By helping resolve the darkness left from many skin conditions, it has truly improved the life and, for some, the job prospects for many of these people. Hydroquinone is in many natural products, e.g. wheat, pears, berries, coffee, tea, onions, rice and red wine, and I am not aware of any cancer induction related to it. Please reconsider this proposed rule. It is unnecessary.