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

---
identifier: "/us/cfr/t21/s357.152"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 357.152 - Package inserts for anthelmintic drug products."
title_number: 21
title_name: "Food and Drugs"
section_number: "357.152"
section_name: "Package inserts for anthelmintic drug products."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "357"
part_name: "MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
cfr_part: "357"
---


# 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]