---
kind: "section"
citation: "21 C.F.R. § 346.12"
title: "21"
number: "346.12"
heading: "Vasoconstrictor active ingredients."
url: "https://uscodex.org/cfr/21/346.12"
---

# §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.

## Notes

### Authority

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

### Source

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