Pediculicide Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph
other · Food and Drug Administration · Rule · Published 2003-12-31 · Effective 2005-06-30 · 68 FR 75414
Document
Document number
03-32100
Federal Register citation
68 FR 75414
CFR reference
21 CFR 358
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-12-31
Effective date
2005-06-30
HHS docket
Docket No. 2002N-0058
Abstract
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements. Pediculicide drug products are used for the treatment of head, pubic (crab), and body lice. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering public comment on its proposed regulation and all relevant data and information that have come to the agency's attention.