"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
- Patients should be cautioned to avoid placing the applicator tip into the ear canal.
- Patients should be cautioned to gently flush the ear with lukewarm water.
- Patients should be warned to use CERUMENEX (triethanolamine polypeptide) Eardrops in ears only. Surrounding skin should be promptly rinsed of any excess drops.
- Patients should be instructed not to leave CERUMENEX (triethanolamine polypeptide) Eardrops in the ear for longer than 30 minutes. A second application may be made, if needed, but more frequent use must be indicated by the physician.
- Patients must be instructed not to exceed the time of exposure, nor to use the medication more frequently than directed by the physician.
- Patients should be advised to discontinue the use of the medication in case of a possible reaction and to consult their physician promptly.
Last reviewed on RxList: 4/27/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Cerumenex Information
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