FDA Proposes New Monograph for Otic Drugs

Topical OTC drugs used for treating or preventing water-clogged ears would get their own labeling rules.

As part of an ongoing review of over-the-counter (OTC) drug products, FDA proposes to make labeling changes for certain otic drugs. The agency has decided that topical OTC drug products for the prevention of swimmer's ear and the drying of water-clogged ears should now receive monograph status.

Previously, the only topical OTC otic drug products with this status were earwax removal aids. FDA did not recognize as safe and effective for OTC use any active ingredients for preventing swimmer's ear and drying water-clogged ears. A rule published in the February 15, 1995, Federal Register [60 FR:8916] stated that no product containing certain ingredients and claiming to be a treatment for those conditions could be introduced, or initially delivered for interstate commerce, after August 15, 1995. The ingredients mentioned in the rule, which included glycerin, anhydrous glycerin, isopropyl alcohol, and acetic acid, all had been proposed as treatments; but the agency deemed them not generally safe or effective.

But part of the rule was stayed one day after it went into effect [60 FR: 42435] when a drug manufacturer submitted new data to support a treatment, consisting of 95% isopropyl alcohol in 5% anhydrous glycerin base, for drying water-clogged ears. The rule remained in effect for the prevention of swimmer's ear and for ingredients not mentioned in the new data, such as acetic acid.

The agency has now accepted the data and is proposing to implement a monograph for certain "ear-drying-aid" drug products. The active ingredient in the monograph is 95% isopropyl alcohol in 5% anhydrous glycerin base.

A 1986 proposal [51 FR:27366– 27373] outlined how monograph labeling would look for these products in case data were submitted warranting any ingredient to be upgraded to monograph status. At that time, the agency said it would allow use of the term water-clogged ears in labeling even though it is not a recognized clinical entity.

It also stated that claims such as "helps relieve the discomfort of water-clogged ears by drying excess water" and "helps dry water in the ear" would be acceptable.

The current proposal calls for similar but more-concise language. Examples include "dries water in the ear" and "dries and relieves water-clogged ears after swimming, showering, bathing, or washing the hair." Other truthful and nonmisleading statements, as provided in 21 CFR 330.1(c)(2), are also allowed.

The proposed warnings are similar to those in the 1986 draft as well. One change is that instead of the warning: "Discontinue use and consult a doctor if undue irritation or sensitivity occurs," the warning should read: "Stop and ask a doctor if irritation (too much burning) or pain occurs." In addition to being more concise, the new wording reflects that the drugs used in the clinical study prompting the monograph produced moderate to severe burning in the ears of some subjects.

All of the new proposed wordings are consistent with the new OTC labeling regulations published earlier this year.

The agency projects a very low cost for relabeling because not many stock-keeping units will be affected, and those that will would have had to have their labels redesigned anyway to comply with the new OTC labeling regulations.

The effective date is proposed to be at least 12 months after a final rule is published.

For further information, contact Elizabeth A. Ryland, Center for Drug Evaluation and Research (HFD-560), FDA, 5600 Fishers Ln., Rockville, MD 20857, 301/ 827-2222.


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