21 CFR § 349.20 - Eyewashes.

---
identifier: "/us/cfr/t21/s349.20"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 349.20 - Eyewashes."
title_number: 21
title_name: "Food and Drugs"
section_number: "349.20"
section_name: "Eyewashes."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "349"
part_name: "OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "53 FR 7090, Mar. 4, 1988, unless otherwise noted."
cfr_part: "349"
---


# 349.20 Eyewashes.

The active ingredient of the product is purified water. The product also contains suitable tonicity agents to establish isotonicity with tears, suitable agents for establishing pH and buffering to achieve the same pH as tears, and a suitable preservative agent.

[68 FR 7921, Feb. 19, 2003]