21 C.F.R. § 524.1662b

Current through September 30, 2024
Section 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

21 C.F.R. §524.1662b

40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10972, Feb. 27, 2014; 88 FR 14901, Mar. 10, 2023
88 FR 14901, 3/10/2023