§ 524.390c - Chloramphenicol-prednisolone-tetracaine-squalane topical suspension.

(a) Specification. Each milliliter contains 4.2 milligrams of chloramphenicol, 1.7 milligrams of prednisolone, 4.2 milligrams of tetracaine, and 0.21 milliliter of squalane.

(b) Sponsor. See No. 017030 in § 510.600(c) of this chapter.

(c) Conditions of use. Dogs and cats. (1) Amount. Apply two or three times daily or as needed for not more than 7 days. Severe infections should be supplemented by systemic therapy.

(2) Indications for use. Treatment of acute otitis externa and pyodermas (acute moist dermatitis, vulvar fold dermatitis, lip fold dermatitis, interdigital dermatitis, and juvenile dermatitis) in dogs and cats.

(3) Limitations. The drug must not be used in the eyes. Prolonged use in cats may produce blood dyscrasias. Laboratory tests should be conducted, including in vitro culturing and susceptibility tests on samples collected prior to treatment. Chloramphenicol products must not be used in meat-, egg-, or milk-producing animals. The length of time that residues persist in milk or tissues has not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian.