§ 524.1484c 21 CFR Ch. I (4–1–12 Edition)

§ 524.1484c Neomycin sulfate, equivalent to 3.5 milligrams of neomy- isoflupredone , tetracaine cin base, 5 milligrams of hydro- hydrochloride ointment. acetate, and 5 milligrams of (a) Specifications. The drug contains 5 tetracaine hydrochloride in each gram milligrams of neomycin sulfate (equiv- of ointment. alent to 3.5 milligrams of neomycin (b) Sponsor. See No. 000009 in base), 1 milligram of isoflupredone ace- § 510.600(c) of this chapter. tate, and 5 milligrams of tetracaine hy- (c) Conditions of use. (1) It is indicated drochloride in each gram of ointment. for treating acute otitis externa and, (b) Sponsor. See No. 000009 in to a lesser degree, chronic otitis § 510.600(c) of this chapter. externa in dogs and cats. In treatment (c) Conditions of use. (1) It is used in of ear canker and other inflammatory treating such conditions as acute otitis conditions of the external ear canal, a externa in dogs and to a lesser degree, quantity of ointment sufficient to fill chronic otitis externa in dogs. It also is the external ear canal may be applied effective in treating anal gland infec- one to three times daily.1 tions and moist dermatitis in the dog (2) Tetracaine and neomycin have the and is a useful dressing for minor cuts, potential to sensitize. Care should be lacerations, abrasions, and post-sur- taken to observe animals being treated gical therapy in the horse, cat, and for evidence of hypersensitivity or al- dog. It may also be used following am- lergy to the product. If such signs are putation of dewclaws, tails and claws, noted, therapy with the product should following ear trimming and castrating be stopped. Incomplete response or ex- operations. acerbation of responsive (2) In treatment of otitis externa and lesions may be due to the presence of other inflammatory conditions of the nonsusceptible organisms or to pro- external ear canal, a quantity of oint- longed use of antibiotic-containing ment sufficient to fill the external ear preparations resulting in overgrowth of canal may be applied one to three nonsusceptible organisms, particularly times daily. When used on the skin or Monilia.1 mucous membranes, the affected area (3) Federal law restricts this drug to should be cleansed, and a small amount use by or on the order of a licensed vet- of the ointment applied and spread or erinarian.1 rubbed in gently. The involved area [40 FR 13873, Mar. 27, 1975, as amended at 49 may be treated one to three times a FR 21922, May 24, 1984] day and these daily applications con- tinued in accordance with the clinical § 524.1484e Neomycin sulfate and poly- response. myxin B sulfate ophthalmic solu- (3) Tetracaine and neomycin have the tion. potential to sensitize. Care should be (a) Specifications. Each milliliter of taken to observe animals being treated the ophthalmic preparation contains for evidence of hypersensitivity or al- 5.0 milligrams neomycin sulfate (3.5 lergy to the drug. If such signs are milligrams neomycin base), and 10,000 noted, therapy with the drug should be Units of polymyxin B sulfate. stopped. Treatment should be limited (b) Sponsor. See No. 000856 in to the period when local anesthesia is § 510.600(c) of this chapter. essential to control self-inflicted trau- (c) Conditions of use. (1) The drug is ma. recommended for the treatment of bac- (4) Federal law restricts this drug to terial infections associated with top- use by or on the order of a licensed vet- ical ophthalmological conditions such erinarian. as corneal injuries, superficial kera- titis, conjunctivitis, keratocon- [40 FR 13873, Mar. 27, 1975, as amended at 43 junctivities, and blepharitis in the dog. FR 18172, Apr. 28, 1978]

§ 524.1484d Neomycin sulfate, hydro- 1 These conditions are NAS/NRC reviewed , tetracaine hydro- and deemed effective. Applications for these chloride ear ointment. uses need not include effectiveness data as specified by § 514.111 of this chapter, but may (a) Specifications. The product con- require bioequivalency and safety informa- tains 5 milligrams of neomycin sulfate, tion.

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