Topical Otic Drug Products
The FDA regulates OTC ear drops and solutions through "OTC Monograph M014: Topical Otic Drug Products for Over-the-Counter Human Use," ensuring their safety and effectiveness as “earwax removal aid.” Or “ear drying aid.” This monograph dictates approved ingredients, labeling requirements, and proper use to keep your ears healthy.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Earwax removal aid active ingredient | |
| Carbamide peroxide 6.5 percent | M014.10 (Part 344) |
| Ear drying aid active ingredient | |
| Isopropyl alcohol 95 percent in an anhydrous glycerin 5 percent base | M014.12 (Part 344) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
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