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Fluocinolone Acetonide 0.01% Recall
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Uses
Fluocinolone acetonide 0.01% Oil Ear Drops is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.
History
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Other Information
Fluocinolone acetonide 0.01% Oil Ear Drops contain fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid.
Chemically, fluocinolone acetonide is C24 H30 F2 O6. It has the following structural formula:
Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each gram of Fluocinolone acetonide 0.01% Oil Ear Drops contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF, and fragrances.
Sources
Fluocinolone Acetonide 0.01% Manufacturers
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Seton Pharmaceuticals
Fluocinolone Acetonide 0.01% | Seton Pharmaceuticals
For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of Fluocinolone acetonide 0.01% Oil 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 Fluocinolone acetonide 0.01% Oil into the ear. Keep head tilted for about a minute to allow Fluocinolone acetonide 0.01% Oil 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.
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