21 CFR 344.50 - Labeling of earwax removal 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 “earwax removal aid.”
(b)Indication. 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.
(c)Warnings. 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.”
(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. The labeling of the product contains the following statement under the heading “Directions”: FOR USE IN THE EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor.