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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 2019.

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, 2019]
[CITE: 21CFR346.52]



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

PART 346 -- ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart C--Labeling

Sec. 346.52 Labeling of permitted combinations of anorectal active ingredients.

Indications, warnings, and directions for use, respectively, 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.

(a) Statement of identity. For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity established in 346.50(a). For a combination drug product that does not have an established name, the labeling of the product states the statement of identity established in 346.50(a).

(b) Indications. The labeling of the product states, under the heading "Indications," the indication(s) for each ingredient in the combination, as established in the indications sections of this subpart.

(c) Warnings. The labeling of the product states, under the heading "Warnings," the warning(s) for each ingredient in the combination, as established in the warnings sections of this subpart.

(d) Directions. The labeling of the product states, under the heading "Directions," directions that conform to the directions established for each ingredient in the directions sections of this subpart. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not exceed any maximum dosage limits established for the individual ingredients in the applicable OTC drug monograph.

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