21 CFR § 357.152 - Package inserts for anthelmintic drug products.

§ 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]