"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 "...
DOSAGE AND ADMINISTRATION
Therapy with this product should be limited to 10 consecutive days.
The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.
For adults, 4 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For infants and children, 3 drops are suggested because of the smaller capacity of the ear canal.
The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further suspension every 4 hours. The wick should be replaced at least once every 24 hours.
SHAKE WELL BEFORE USING.
Bottle of 7.5 mL with sterilized dropper (NDC 61570-038-75). Store at 15° to 25°C (59° to 77°F).
Distributed by: Prescribing information as of April 2003. Monarch Pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/23/2009
Additional Pediotic Information
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