"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 "...
For removal of impacted cerumen prior to ear examination, otologic therapy and/or audiometry.
DOSAGE AND ADMINISTRATION
- Fill ear canal with CERUMENEX Eardrops with the patient's head tilted at a 45° angle.
- Insert cotton plug and allow to remain 15-30 minutes.
- Then gently flush with lukewarm water, using a soft rubber syringe (avoid excessive pressure). Exposure of skin outside the ear to the drug should be avoided. The procedure may be repeated if the first application fails to clear the impaction.
FOR EXTERNAL USE IN THE EAR ONLY
CERUMENEX Eardrops (triethanolamine polypeptide oleate-condensate) are supplied in 6 Ml (NDC 0034-5490-06) and 12 mL (NDC 0034-5490-12) bottles with a cellophane wrapped dropper.
Store at controlled room temperature 15-30°C (59-86°F). Store in a dry place.
The Purdue Frederick Company, Stamford, CT 06901-3431. Revised: Nov 2001This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/21/2017
Additional Cerumenex Information
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