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Electronic Code of Federal Regulations

e-CFR data is current as of December 6, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1662b


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS


§524.1662b   Oxytetracycline and polymyxin B ophthalmic ointment.

(a) Specifications. Each gram of the ointment contains oxytetracycline hydrochloride equivalent to 5 milligrams of oxytetracycline and 10,000 units of polymyxin B sulfate.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount. Administer topically to the eye two to four times daily.

(2) Indications for use. For the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms including ocular infections due to streptococci, rickettsiae, E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in dogs, cats, cattle, sheep, and horses); ocular infections due to secondary bacterial complications associated with distemper in dogs; and ocular infections due to bacterial inflammatory conditions which may occur secondary to other infectious diseases in dogs, cats, cattle, sheep, and horses.

(3) Limitations. Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.

[40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014]

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