# Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment
> **Food and Drug Administration** · Final rule; technical amendment. · Published 2008-02-01 · Effective 2008-03-03 · 73 FR 6014
## Document
- **Document number:** E8-1818
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 73 FR 6014
- **CFR reference:** 21 CFR 347
- **Publication date:** 2008-02-01
- **Effective date:** 2008-03-03
- **HHS docket:** Docket Nos. 1978N-0021 and 1978N-0021P
## Abstract

The Food and Drug Administration (FDA) is amending the regulation that establishes conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective (GRASE) and not misbranded. This amendment revises labeling requirements for OTC skin protectant drug products formulated and marketed as lip protectants.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2008/02/01/E8-1818/skin-protectant-drug-products-for-over-the-counter-human-use-reduced-labeling-technical-amendment)
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