CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 344—TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART A—General Provisions (§344.1 to §344.3) > 344.3—Definitions.

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.

Code of Federal Regulations

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