21 CFR § 344.52 - Labeling of ear drying aid drug products.
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “ear drying aid.”
(b) Indications. 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] 1 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.
1 See § 201.66(b)(4) of this chapter.
(c) Warnings. The labeling of the product contains the following warnings under the heading “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. The labeling of the product contains the following statement under the heading “Directions”: [optional, bullet] “apply 4 to 5 drops in each affected ear.”
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