Current through May 31, 2024
Section 524.1484d - Neomycin, hydrocortisone, and tetracaine otic 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. 054771 in § 510.600(c) of this chapter.(c)Conditions of use in dogs and cats -(1)Amount. Instill a quantity of ointment sufficient to fill the external ear canal; may be applied one to three times daily.(2)Indications for use. For the treatment of ear canker and other inflammatory conditions of the external ear canal, acute otitis externa and, to a lesser degree, chronic 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 49 FR 21922, May 24, 1984; 79 FR 10970, Feb. 27, 2014