"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 "...
ACUTE OTITIS MEDIA OF VARIOUS ETIOLOGIES
Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, especially in children in whom the tube is shorter, wider, and more horizontal than in adults.
REMOVAL OF CERUMEN
facilitates the removal of excessive or impacted cerumen
DOSAGE AND ADMINISTRATION
Instill Auralgan (antipyrine, benzocaine and glycerin dehydrated) permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Auralgan (antipyrine, benzocaine and glycerin dehydrated) and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.
REMOVAL OF CERUMEN
Before: Instill Auralgan (antipyrine, benzocaine and glycerin dehydrated) three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.
After: Auralgan (antipyrine, benzocaine and glycerin dehydrated) is useful for drying out the canal or relieving discomfort.
Before and after removal of cerumen, a cotton pledget moistened with Auralgan (antipyrine, benzocaine and glycerin dehydrated) should be inserted into the meatus following instillation.
Note: Do not rinse dropper after use.
Replace dropper in bottle after each use. Hold dropper assembly by screw cap and, without compressing the rubber bulb, insert into drug container and screw down tightly.
Protect the solution from light and heat, and do not use if it is brown or contains a precipitate.
DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION.
Auralgan (antipyrine, benzocaine and glycerin dehydrated) ® Otic Solution, in package containing 10 mL bottle with separate dropper-screw cap attachment (NDC 0046-1000-10).
Store at room temperature (approximately 25° C).
Ayerst Laboratories Inc.
A Wyeth-Ayerst Company
Philadelphia, PA 19101
Last reviewed on RxList: 12/8/2004
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