21 CFR Part 344 — Topical Otic Drug Products for Over-the-Counter Human Use

PART 344—TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 51 FR 28660, Aug. 8, 1986, unless otherwise noted. Subpart A—General Provisions § 344.1 Scope. (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. § 344.3 Definitions. As used in this part: (a) Anhydrous glycerin. (b) Earwax removal aid. (c) Water-clogged ears. (d) Ear drying aid. [51 FR 28660, Aug. 8, 1986, as amended at 65 FR 48905, Aug. 10, 2000] Subpart B—Active Ingredients § 344.10 Earwax removal aid active ingredient. 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] § 344.12 Ear drying aid active ingredient. 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] Subpart C—Labeling § 344.50 Labeling of earwax removal aid drug products. (a) Statement of identity. (b) Indication. (c) 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.” (3) “Do not use for more than 4 days; if excessive earwax remains after use of this product, consult a doctor.” (4) “Avoid contact with the eyes.” (d) Directions. [51 FR 28660, Aug. 8, 1986; 52 FR 7830, Mar. 13, 1987; 65 FR 48905, Aug. 10, 2000] § 344.52 Labeling of ear drying aid drug products. (a) Statement of identity. (b) Indications. 1 1 (c) Warnings. (1) “Flammable [in bold type]: Keep away from fire or flame.” (2) “Do not use [in bold type] in the eyes.” (3) “Ask a doctor before use if you have [in bold type] [bullet] ear drainage or discharge [bullet] pain, irritation, or rash in the ear [bullet] had ear surgery [bullet] dizziness.” (4) “Stop use and ask a doctor if [in bold type] irritation (too much burning) or pain occurs.” (d) Directions. [65 FR 48905, Aug. 10, 2000]

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