§ 349.12. Ophthalmic demulcents.
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/us/cfr/t21/s§ 349.12·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. [53 FR 7090, Mar. 4, 1988, as amended at 68 FR 32982, June 3, 2003]