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21 C.F.R. § 357.152   Package inserts for anthelmintic drug products.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Anthelmintic Drug Products

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§ 357.152   Package inserts for anthelmintic drug products.

The labeling of the product contains a consumer package insert which includes the following information:

(a) A discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be visually identified before taking this medication.

(b) A detailed description of how to find and identify the pinworm.

(c) A commentary on the life cycle of the pinworm.

(d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading.

(e) The appropriate labeling information contained in §357.150

(Collection of information requirement approved by the Office of Management and Budget under control number 0910–0232)

[51 FR 27759, Aug. 1, 1986, as amended at 52 FR 2515, Jan 23, 1987]

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