Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Amendment to the Monograph
other · Food and Drug Administration · Rule · Published 2007-03-06 · Effective 2007-04-05 · 72 FR 9849
Document
Document number
E7-3808
Federal Register citation
72 FR 9849
CFR reference
21 CFR 310
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-03-06
Effective date
2007-04-05
HHS docket
Docket No. 2005N-0448
Abstract
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA did not receive any comments or data in response to its previously proposed rule to include this combination. This final rule is part of FDA's ongoing review of OTC drug products.