"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
For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of DermOtic® Oil (fluocinolone acetonide oil ear drops) into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe backward and upward and apply 5 drops of DermOtic® Oil (fluocinolone acetonide oil ear drops) into the ear. Keep head tilted for about a minute to allow DermOtic® Oil (fluocinolone acetonide oil ear drops) to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.
DermOtic® Oil (fluocinolone acetonide oil) 0.01% Ear Drops is supplied in 1 fluid ounce bottles containing 20 mL, net weight (Dropper Included) (NDC # 28105-160-20).
Keep tightly closed. Store at 20°-25°C (68°to 77°F); excursions permitted to 15°-30°C (59°-86°F.) [see
USP Controlled Room Temperature]
CAUTION: Rx only
MANUFACTURED AND DISTRIBUTED BY:
Hill Dermaceuticals, Inc.
Sanford, Florida 32773
Rev. CODE 171A175
Last reviewed on RxList: 3/3/2009
Additional DermOtic Oil Information
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