[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.390c]

[Page 292]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 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 Sec. 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.

[57 FR 37334, Aug. 18, 1992]