21 CFR § 344.3 - Definitions.

---
identifier: "/us/cfr/t21/s344.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 344.3 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "344.3"
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: "344"
part_name: "TOPICAL OTIC 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: "51 FR 28660, Aug. 8, 1986, unless otherwise noted."
cfr_part: "344"
---


# 344.3 Definitions.

As used in this part:

(a) *Anhydrous glycerin.* An ingredient that may be prepared by heating glycerin U.S.P. at 150 °C for 2 hours to drive off the moisture content.

(b) *Earwax removal aid.* A drug used in the external ear canal that aids in the removal of excessive earwax.

(c) *Water-clogged ears.* The retention of water in the external ear canal, thereby causing discomfort and a sensation of fullness or hearing impairment.

(d) *Ear drying aid.* A drug used in the external ear canal to help dry water-clogged ears.

[51 FR 28660, Aug. 8, 1986, as amended at 65 FR 48905, Aug. 10, 2000]