CFR

524.981e—Fluocinolone acetonide, dimethyl sulfoxide otic solution.

(a) Specifications. Each milliliter of solution contains 0.01 percent of fluocinolone acetonide in 60 percent dimethyl sulfoxide with propylene glycol and citric acid.

(b) Sponsor. See No. 000033 in § 510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs for the relief of pruritis and inflammation associated with acute and chronic otitis.

(2) It is administered at 4 to 6 drops (0.2 milliliter) twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 milliliters. The ear canal should be cleansed by some appropriate method prior to instillation of the solution and the ear should be massaged gently following instillation.

(3) There should be careful initial evaluation and followup of infected ears. Incomplete response or exacerbation of corticosteroid-responsive lesions may be due to the presence of an infection which requires identification or antibiotic sensitivity testing, and the use of the appropriate antimicrobial agent. As with any corticosteroid, animals with a generalized infection should not be treated with this product without proper supportive antimicrobial therapy. Preparations with dimethyl sulfoxide should not be used in pregnant animals. For use by or on the order of a licensed veterinarian.

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