§349.12. Ophthalmic demulcents.

21 C.F.R. § 349.12

The active ingredients of the product consist of any of the following, within the established concentrations for each ingredient:

(a)

Cellulose derivatives—

(1)

Carboxymethylcellulose sodium, 0.2 to 2.5 percent.

(2)

Hydroxyethyl cellulose, 0.2 to 2.5 percent.

(3)

Hypromellose, 0.2 to 2.5 percent.

(4)

Methylcellulose, 0.2 to 2.5 percent.

(b)

Dextran 70, 0.1 percent when used with another polymeric demulcent agent in this section.

(c)

Gelatin, 0.01 percent.

(d)

Polyols, liquid—

(1)

Glycerin, 0.2 to 1 percent.

(2)

Polyethylene glycol 300, 0.2 to 1 percent.

(3)

Polyethylene glycol 400, 0.2 to 1 percent.

(4)

Polysorbate 80, 0.2 to 1 percent.

(5)

Propylene glycol, 0.2 to 1 percent.

(e)

Polyvinyl alcohol, 0.1 to 4 percent.

(f)

Povidone, 0.1 to 2 percent.

Notes, amendments, and revision history

[53 FR 7090, Mar. 4, 1988, as amended at 68 FR 32982, June 3, 2003]

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

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

[53 FR 7090, Mar. 4, 1988, as amended at 68 FR 32982, June 3, 2003]