21 CFR § 347.3 - Definitions.
---
identifier: "/us/cfr/t21/s347.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 347.3 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "347.3"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "347"
part_name: "SKIN PROTECTANT 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."
regulatory_source: "58 FR 54462, Oct. 21, 1993, unless otherwise noted."
cfr_part: "347"
---
# 347.3 Definitions.
As used in this part:
*Astringent drug product.* A drug product applied to the skin or mucous membranes for a local and limited protein coagulant effect.
*Lip protectant drug product.* A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called “lip balm.”
*Poison ivy, oak, sumac dermatitis.* An allergic contact dermatitis due to exposure to plants of the genus Rhus (poison ivy, poison oak, poison sumac), which contain urushiol, a potent skin-sensitizer.
*Skin protectant drug product.* A drug product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.
[68 FR 33376, June 4, 2003]