§349.18. Ophthalmic vasoconstrictors.

21 C.F.R. § 349.18

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.

Notes, amendments, and revision history

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

Source: 53 FR 7090, Mar. 4, 1988, unless otherwise noted.