# Ophthalmic Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph
> **Food and Drug Administration** · Final rule. · Published 2000-06-21 · Effective 2002-05-16 · 65 FR 38426
## Document
- **Document number:** 00-15631
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 38426
- **CFR reference:** 21 CFR 349
- **Publication date:** 2000-06-21
- **Effective date:** 2002-05-16
- **HHS docket:** Docket No. 98N-0002
## Abstract

The Food and Drug Administration (FDA) is amending the monograph for over-the-counter (OTC) ophthalmic 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 new warning and revises an existing warning for ophthalmic vasoconstrictor drug products. These products contain the ingredients ephedrine hydrochloride, naphazoline hydrochloride, phenylephrine hydrochloride, or tetrahydrozoline hydrochloride and are used to relieve redness of the eye due to minor eye irritations. 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/2000/06/21/00-15631/ophthalmic-drug-products-for-over-the-counter-human-use-amendment-of-final-monograph)
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