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
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.