21 CFR § 344.3
Definitions
June 25, 2020
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]
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