21 C.F.R. § 524.981d Fluocinolone acetonide, dimethyl sulfoxide solution.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 20 percent dimethyl sulfoxide with propylene glycol and citric acid. (b) Sponsor. See No. 000856 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is used in dogs for the relief of impaction commonly present in apparently normal anal sacs, for the reversal of inflammatory changes associated with abnormal anal sacs, and to counteract the offensive odor of anal sac secretions. (2) It is administered by instillation of 1 to 2 milliliters into each anal sac following expression of anal sac contents. It may be necessary to repeat treatment at 60-day intervals to maintain an odor-free state. The total dosage used should not exceed 2 milliliters per anal sac per treatment. (3) For use only by or on the order of a licensed veterinarian. [40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.981d Fluocinolone acetonide, dimethyl sulfoxide solution.
