CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART B—Anthelmintic Drug Products (§357.101 to §357.180) > 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)

Code of Federal Regulations

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