# Pediculicide Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph
> **Food and Drug Administration** · Final rule. · Published 2003-12-31 · Effective 2005-06-30 · 68 FR 75414
## Document
- **Document number:** 03-32100
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 75414
- **CFR reference:** 21 CFR 358
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/12/31/03-32100/pediculicide-drug-products-for-over-the-counter-human-use-amendment-of-final-monograph)
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