# Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2003-12-09 · Effective 2004-06-04 · 68 FR 68509
## Document
- **Document number:** 03-30394
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 68509
- **CFR reference:** 21 CFR 347
- **Publication date:** 2003-12-09
- **Effective date:** 2004-06-04
- **HHS docket:** Docket Nos. 78N-0021 and 78N-021P
## Abstract

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/12/09/03-30394/skin-protectant-drug-products-for-over-the-counter-human-use-final-monograph-technical-amendment)
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