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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 Nov 29, 2022.

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

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[Code of Federal Regulations]
[Title 21, Volume 5]
[CITE: 21CFR349.50]



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 C - Labeling

Sec. 349.50 Labeling of ophthalmic drug products.

(a) The word "physician" may be substituted for the word "doctor" in any of the labeling statements in this part.

(b) Where applicable, indications in this part applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this part, may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(c) The labeling of the product contains the following warnings, under the heading "Warnings":

(1) For ophthalmic drug products packaged in multi-use containers. "To avoid contamination, do not touch tip of container to any surface. Replace cap after using."

(2) For ophthalmic drug products packaged in single-use containers. "To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard."

(3) For ophthalmic drug products containing mercury compounds used as a preservative. "This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to" (select one of the following: "mercury" or "(insert name of mercury-containing ingredient) or any other ingredient containing mercury)."

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