CFR

524.1484d—Neomycin sulfate, hydrocortisone acetate, tetracaine hydrochloride ear ointment.

(a) Specifications. The product contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, 5 milligrams of hydrocortisone acetate, and 5 milligrams of tetracaine hydrochloride in each gram of ointment.

(b) Sponsor. See No. 000009 in § 510.600(c) of this chapter.

(c) Conditions of use. (1) It is indicated for treating acute otitis externa and, to a lesser degree, chronic otitis externa in dogs and cats. In treatment of ear canker and other inflammatory conditions of the external ear canal, a quantity of ointment sufficient to fill the external ear canal may be applied one to three times daily. 1

(2) Tetracaine and neomycin have the potential to sensitize. Care should be taken to observe animals being treated for evidence of hypersensitivity or allergy to the product. If such signs are noted, therapy with the product should be stopped. Incomplete response or exacerbation of corticosteroid responsive lesions may be due to the presence of nonsusceptible organisms or to prolonged use of antibiotic-containing preparations resulting in overgrowth of nonsusceptible organisms, particularly Monilia. 1

Code of Federal Regulations

Footnote(s): 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. 1

Code of Federal Regulations

[40 FR 13873, Mar. 27, 1975, as amended at 49 FR 21922, May 24, 1984]

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