Neo-Cortef® with Tetracaine

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

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.

Conditions of use:

Dogs

Amount: A quantity of ointment sufficient to fill the external ear canal may be applied one to three times daily.

Indications: It is indicated for treating acute otitis externa and, to a lesser degree, chronic otitis externa in dogs. In treatment of ear canker and other inflammatory conditions of the external ear canal.

Limitations: 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 non susceptible organisms or to prolonged use of antibiotic-containing preparations resulting in overgrowth of non susceptible organisms, particularly Monilia. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Amount: A quantity of ointment sufficient to fill the external ear canal may be applied one to three times daily.

Indications: It is indicated for treating acute otitis externa and, to a lesser degree, chronic otitis externa in cats. In treatment of ear canker and other inflammatory conditions of the external ear canal.

Limitations: 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 non susceptible organisms or to prolonged use of antibiotic-containing preparations resulting in overgrowth of non susceptible organisms, particularly Monilia. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

NAS/NRC status: 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.

Tolerances are established for residues of parent neomycin in uncooked edible tissues as follows:

a. In cattle, swine, sheep, and goats: 7.2 parts per million in kidney (target tissue) and fat, 3.6 ppm in liver, and 1.2 ppm in muscle.

b. In turkeys: 7.2 ppm in skin with adhering fat, 3.6 parts per million in liver, and 1.2 ppm in muscle.

c. In milk: 0.15 part per million.

A tolerance is established for negligible residues of hydrocortisone (as hydrocortisone sodium succinate or hydrocortisone acetate) in milk at 10 parts per billion.