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Business · 15/02/1995Updated: 10/18/2026 · 1 min read

FDA Issues Final Rule on Over-the-Counter Topical Otic Drugs for Swimmer's Ear and Water-Clogged Ears

Summary

The FDA is issuing a final rule stating that over-the-counter topical otic drugs for preventing swimmer's ear or drying water-clogged ears are not safe and effective, and therefore misbranded, following public comments and new data on the topic.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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