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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 454.100 OTC Ear Drop Preparations May 1987

Final
Docket Number:
None found
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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

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All written comments should be identified with this document's docket number: None found.

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