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The FDA sent warning letters to four earache medication makers demanding that the companies stop marketing their products, which the FDA has determined to be prescription drugs, as over-the-counter medicine.
The companies and their products are as follows:
Homeolab USA Inc. | Kids Relief Earache
Insight Pharmaceuticals, LLC | Auro Earache Relief Ear Drops
Medtech Products, Inc. | Murine Ear Drops for Earache Relief
Topco Associates, LLC | TopCare Earache Relief Ear Drops
According to the FDA, it asked that the products be pulled because:
OTC treatment is inappropriate for ear pain because consumers cannot distinguish its symptoms from those of more serious disorders of the ear or adjacent tissues which are not amenable to OTC treatment and which can lead to serious injury if not accurately diagnosed and treated by a licensed healthcare professional.
Consumers should stay away from anything advertised as over-the-counter earache medication, and check with your doctor should you feel ear pain.
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