Code of Federal Regulations · Section

§ 357.152 — Package Inserts For Anthelmintic Drug Products

21 C.F.R. § 357.152

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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

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