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.
REGULATORY ACTION GUIDANCE:
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