Definitions.

21 C.F.R. § 344.3
in effectEffective: 2024-07-01
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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.

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