# Pediculicide Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 1998-08-13 · Effective 1998-09-14 · 63 FR 43302
## Document
- **Document number:** 98-21794
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 43302
- **CFR reference:** 21 CFR 358
- **Publication date:** 1998-08-13
- **Effective date:** 1998-09-14
- **HHS docket:** Docket No. 81N-0201
## Abstract

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) pediculicide drug products (products used for the treatment of head, pubic (crab), and body lice) are generally recognized as safe and effective and not misbranded. This final rule clarifies that the pediculicide active ingredient, pyrethrum extract, is to provide a specified concentration range of pyrethrins in a formulated product. This final rule is part of the ongoing review of OTC drug products conducted by FDA.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/08/13/98-21794/pediculicide-drug-products-for-over-the-counter-human-use-final-monograph-technical-amendment)
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