21 CFR § 524.1484g Ophthalmic and Topical Dosage Form New Animal Drugs

§ 524.1484g Neomycin, thiabendazole, and dexamethasone solution.

Current through Sep 8, 2026 · Read all of Part 524

(a) Specifications. Each milliliter of solution contains 40 milligrams (mg) thiabendazole, 3.2 mg neomycin (from neomycin sulfate), and 1 mg dexamethasone.

(b) Sponsors. See Nos. 000010 and 017033 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount. In treating dermatoses affecting areas other than the ear, the surface of the lesions should be well moistened (2 to 4 drops per square inch) twice daily. In treating otitis externa, instill 5 to 15 drops in the ear twice daily. Treat for up to 7 days.

(2) Indications for use. As an aid in the treatment of bacterial, mycotic, and inflammatory dermatoses and otitis externa.

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

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997; 79 FR 10971, Feb. 27, 2014; 80 FR 61297, Oct. 13, 2015; 84 FR 39184, Aug. 9, 2019; 88 FR 16549, Mar. 20, 2023]

← § 524.1484f Neomycin, prednisolone, and tetracaine otic suspension.§ 524.1484h Neomycin, penicillin, polymyxin B, and hydrocortisone suspension. →