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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 454.100 OTC Ear Drop Preparations

 

BACKGROUND:
 

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
 

or
 

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

REMARKS:
 

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