21 CFR 346.12 - Vasoconstrictor active ingredients.

Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

View all text of Subpart B [§ 346.10 - § 346.22]

§ 346.12 - Vasoconstrictor active ingredients.

The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient.

(a) Ephedrine sulfate 0.1 to 1.25 percent.

(b) Epinephrine 0.005 to 0.01 percent.

(c) Epinephrine hydrochloride 0.005 to 0.01 percent.

(d) Phenylephrine hydrochloride 0.25 percent.

authority: 21 U.S.C. 321,351,352,353,355,360,371

source: 55 FR 31779, Aug. 3, 1990, unless otherwise noted.

cite as: 21 CFR 346.12