# Topical Drug Products for Over-the-Counter Human Use; Products for the Prevention of Swimmer's Ear and for the Drying of Water-Clogged Ears; Partial Stay of Final Rule
> **Food and Drug Administration** · Final rule; partial stay of regulation. · Published 1995-08-16 · Effective 1995-06-22 · 60 FR 42435
## Document
- **Document number:** 95-20315
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 60 FR 42435
- **CFR reference:** 21 CFR 310
- **Publication date:** 1995-08-16
- **Effective date:** 1995-06-22
- **HHS docket:** Docket No. 77N-334S
## Abstract

The Food and Drug Administration (FDA) is staying part of a final rule that established that any over-the-counter (OTC) topical otic drug products for the prevention of swimmer's ear or for the drying of water-clogged ears is not generally recognized as safe and effective and is misbranded. This action, which is being taken in response to new clinical data and a petition for stay of action, applies only to topical otic drug products for the drying of water- clogged ears. This action is part of the ongoing review of OTC drug products conducted by FDA.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1995/08/16/95-20315/topical-drug-products-for-over-the-counter-human-use-products-for-the-prevention-of-swimmers-ear-and)
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