21 C.F.R. § 344.3
Definitions.
Cite as 21 C.F.R. § 344.3 (2026)
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]