§ 524.390a - Chloramphenicol ophthalmic ointment.

Link to an amendment published at 77 FR 4897, Feb. 1, 2012.

(a) Specifications. Each gram contains 10 milligrams chloramphenicol in a petrolatum base.

(b) Sponsor. See Nos. 000856 and 025463 in §510.600(c) of this chapter for use as in paragraph (c)(1)(i) of this section. See No. 017030 for use as in paragraph (c)(1)(ii) of this section.

(c) Conditions of use. Dogs and cats —(1) Amount. Apply as follows:

(i) Every 3 hours around the clock for 48 hours after which night instillations may be omitted.

(ii) Four to six times daily to affected eye for the first 72 hours depending upon the severity of the condition. A small amount of ointment should be placed in the lower conjunctival sac.

(2) Indications for use. Treatment of bacterial conjunctivitis caused by pathogens susceptible to chloramphenicol.

(3) Limitations. Continue treatment for 48 hours (2 days) after eye appears normal. Therapy for cats should not exceed 7 days. Prolonged use in cats may produce blood dyscrasias. If improvement is not noted in a few days a change of therapy should be considered. When infection may be cause of disease, especially in purulent or catarrhal conjunctivitis, attempts should be made to determine through susceptibility testing, which antibiotics will be effective prior to applying ophthalmic preparations. This chloramphenicol product must not be used in animals producing meat, eggs, or milk. 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 37333, Aug. 18, 1992]