# Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph for OTC First Aid Antibiotic Drug Products
> **Food and Drug Administration** · Final rule. · Published 1996-11-15 · Effective 1997-11-17 · 61 FR 58471
## Document
- **Document number:** 96-29302
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 61 FR 58471
- **CFR reference:** 21 CFR 333
- **Publication date:** 1996-11-15
- **Effective date:** 1997-11-17
- **HHS docket:** Docket No. 95N-0062
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule amending the monograph for over-the-counter (OTC) first aid antibiotic drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded). The amendment adds a warning statement concerning allergic reactions resulting from topical antibiotic drug products containing bacitracin, bacitracin zinc, neomycin, neomycin sulfate, polymyxin B, or polymyxin B sulfate. 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/1996/11/15/96-29302/topical-antimicrobial-drug-products-for-over-the-counter-human-use-amendment-of-final-monograph-for)
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