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Electronic Code of Federal Regulations

e-CFR data is current as of December 4, 2019

Title 21Chapter ISubchapter EPart 524 → §524.981e


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS


§524.981e   Fluocinolone and dimethyl sulfoxide otic solution.

(a) Specifications. Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 60 percent dimethyl sulfoxide.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount—Instill 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.

(2) Indications for use. For the relief of pruritis and inflammation associated with acute and chronic otitis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10969, Feb. 27, 2014]

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