GroundRules
21 CFR 357.152: Package inserts for anthelmintic drug products.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 357—MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—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
Collected 2026-08-27T02:24:47Z. Source file · JSON