21 CFR § 349.18 - Ophthalmic vasoconstrictors.

---
identifier: "/us/cfr/t21/s349.18"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 349.18 - Ophthalmic vasoconstrictors."
title_number: 21
title_name: "Food and Drugs"
section_number: "349.18"
section_name: "Ophthalmic vasoconstrictors."
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"
---


# 349.18 Ophthalmic vasoconstrictors.

The active ingredient of the product consists of one of the following, within the established concentration for each ingredient:

(a) Ephedrine hydrochloride, 0.123 percent.

(b) Naphazoline hydrochloride, 0.01 to 0.03 percent.

(c) Phenylephrine hydrochloride, 0.08 to 0.2 percent.

(d) Tetrahydrozoline hydrochloride, 0.01 to 0.05 percent.