Current through October 31, 2024
Section 344.3 - DefinitionsAs 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