Sec. 454.100 OTC Ear Drop Preparations (CPG 7132b.01)
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