- (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]