Inspections, Compliance, Enforcement, and Criminal Investigations

CPG Sec. 454.100 OTC Ear Drop Preparations


It has been our policy <> that the only acceptable claim for over-the-counter distribution of ear drops is for the loosening of wax. The inclusion of a local anesthetic agent in an ear drop whose primary function is to soften wax is irrational and may mask an acute infection.


The following represents criteria for recommending legal action to the *Division of Drug Labeling Compliance, HFD-310*:

Any ear drop preparation offered for over-the-counter distribution that contains a local anesthetic


Any ear drop preparation offered for over-the-counter distribution with claims offering the product for conditions other than "for the loosening of wax."


Some of these preparations may be suitable for marketing as prescription drugs.

*Material between asterisks is new or revised*
<> Indicates material has been deleted
Issued: 10/1/80
Revised: 5/22/87

Page Last Updated: 03/20/2015
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