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Code of Federal Regulations Title 21. Food and Drugs § 21.349.12 Ophthalmic demulcents

Current as of January 02, 2025 | Updated by Findlaw Staff

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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.349.12 Ophthalmic demulcents - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-349-12/

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