For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

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 10 mL with sterilized dropper. (NDC 61570-033-10).

Store at 15° to 25°C (59° to 77°F).

Also Available: CORTISPORIN® Otic Solution bottle of 10 mL with sterilized dropper. PEDIOTIC® Suspension bottle of 7.5 mL with sterilized dropper.

Prescribing Information as of November 2003. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834. FDA Rev date: 8/10/2000

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