§357.152. Package inserts for anthelmintic drug products.
21 C.F.R. § 357.152
The labeling of the product contains a consumer package insert which includes the following information:
A discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be visually identified before taking this medication.
A detailed description of how to find and identify the pinworm.
A commentary on the life cycle of the pinworm.
A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading.
The appropriate labeling information contained in § 357.150
Notes, amendments, and revision history
Amendments
[51 FR 27759, Aug. 1, 1986, as amended at 52 FR 2515, Jan. 23, 1987]
Source
Source: 51 FR 27759, Aug. 1, 1986, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Amendments
[51 FR 27759, Aug. 1, 1986, as amended at 52 FR 2515, Jan. 23, 1987]