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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2017]
[CITE: 21CFR349.12]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE

PART 349 -- OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart B--Active Ingredients

Sec. 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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