Title 21 CFR reference

(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part in addition to each of the general conditions established in § 330.1. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

The active ingredient of the product consists of carbamide peroxide 6.5 percent formulated in an anhydrous glycerin vehicle. [51 FR 28660, Aug. 8, 1986, as amended at 65 FR 48905, Aug. 10, 2000]

The active ingredient of the product consists of isopropyl alcohol 95 percent in an anhydrous glycerin 5 percent base. [65 FR 48905, Aug. 10, 2000]

As used in this part: Anhydrous glycerin.(a) An ingredient that may be prepared by heating glycerin U.S.P. at 150 °C for 2 hours to drive off the moisture content. Earwax removal aid.(b) A drug used in the external ear canal that aids in the removal of excessive earwax. Water-clogged ears.(c) The retention of water in the external ear canal, thereby causing discomfort and a sensation of fullness or hearing impairment. Ear drying aid.(d) 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]

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “earwax removal aid.” Indication.(b) The labeling of the product states, under the heading “Indication,” the following: “For occasional use as an aid to” (which may be followed by: “soften, loosen, and”) “remove excessive earwax.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. Warnings.(c) The labeling of the product contains the following warnings under the heading “Warnings”: (1) “Do not use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor.” (2) “Do not use if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor.”…

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “ear drying aid.” Indications.1(b) The labeling of the product states, under the heading “Use,” the following: “dries water in the ears” (optional, which may be followed by: “and relieves water-clogged ears”) (which may be followed by any or all of the following: “after: [bullet] swimming [bullet] showering [bullet] bathing [bullet] washing the hair”). Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. Warnings.(c) The labeling of the product contains the following warnings under the heading “Warnings”: (1) “Flammable [in bold type]: Keep away from fire or flame.”…