Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 524.1662b: b 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Where this section sits in the code

Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

(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.

(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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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