21 CFR §524.1484d

1. (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.
2. (b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
3. (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.
   1. (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.
   2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.