"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
Carefully remove all cerumen and debris to allow Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Acetic Acid Otic Solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of Acetic Acid Otic Solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Acetic Acid Otic Solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.
Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL and 30 mL measured-drop, safety-tip plastic bottles.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
Manufactured by: VINTAGE PHARMACEUTICALS, LLC, Huntsville, AL 35811. 8180671 R3/05. FDA Rev date: 2/24/2005
Last reviewed on RxList: 11/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Acetic Acid Information
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