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Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE / PART 349 - OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE / Subpart B - Active Ingredients / § 349.12 Ophthalmic demulcents.
§ 349.12 Ophthalmic demulcents.

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]
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