522.960b—Flumethasone acetate injection.

(a) Chemical name. 6-alpha,9-alpha-difluoro - 16 - alpha - methylprednisolone 21-acetate.
(b) Specifications. Flumethasone injection is sterile and contains per cubic centimeter: 2 milligrams of flumethasone acetate; 20 milligrams of propylene glycol; 9 milligrams of benzyl alcohol (as preservative); 8 milligrams of sodium chloride; 1 milligram of polysorbate 80; 0.1 milligram of citric acid; water for injection q.s.
(c) Sponsor. See No. 000856 in § 510.600(c) of this chapter.
(d) Conditions of use. (1) It is recommended in certain acute and chronic canine dermatoses of varying etiology to help control the pruritus, irritation, and inflammation associated with these conditions.
(2) The drug is administered intramuscularly at the following recommended daily dosage:
Weight of animal in pounds Dosage in milligrams
Up to 10 1.0
10 to 25 2.0
25 and over 4.0
Dosage should be adjusted according to the weight of the animal, the severity of the symptoms, and the response noted. Dosage by injection should not exceed 3 days of therapy. With chronic conditions intramuscular therapy may be followed by oral administration of flumethasone tablets at a daily dose of from 0.0625 to 0.25 milligram per animal.
(3) For use only by or on the order of a licensed veterinarian.

Code of Federal Regulations

[40 FR 13858, Mar. 27, 1975. Redesignated at 44 FR 16011, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996]