§344.3. Definitions.

21 C.F.R. § 344.3

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.

Notes, amendments, and revision history

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

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

Source: 51 FR 28660, Aug. 8, 1986, unless otherwise noted.

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