21 CFR 346.12
§ 346.12 Vasoconstrictor active ingredients.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 346.12, § 346.12 Vasoconstrictor active ingredients, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86619
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.