1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC162
Submitter : Ms. Christine Fairchild Date & Time: 12/20/2006 08:12:37
Organization : Ms. Christine Fairchild
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The removal of hydroquinone from the over-the-counter market would significantly impact millions of consumers who either have no access to prescriptions and medical care or are unaware of their availability.

Prescription hydroquinone products are typically not covered by medical insurance and are far too expensive for most patients, unlike those hydroquinone-based bleaches which are easily available over-the-counter.

Since 1961, hydroquinone has demonstrated a safe and effect profile among clinicians prescribing or recommending hydroquinone products. Therefore, I, as a Medical Aesthetics Nurse Specialitst, do not agree with your proposed action of removing hydroquinone from the OTC market. Thank you.