GroundRules
21 CFR 344.3: Definitions.
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 344—TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart A—General Provisions
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON