Code · CFR · Title 21 — Food and Drugs · Part 344 — Topical Otic Drug Products for Over-the-Counter Human Use · § 344.3

§ 344.3. Definitions.

105 words·~1 min read·/us/cfr/t21/s§ 344.3

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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]