21 CFR §524.1484f

1. (a)Specifications. The product contains 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base, 2.5 milligrams of prednisolone acetate, and 5 milligrams of tetracaine hydrochloride in each milliliter of sterile suspension.
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 2 to 6 drops in the external ear canal 2 or 3 times daily.
   1. (2)Indications for use. For the treatment of acute otitis externa and, to a lesser degree, chronic otitis externa; as treatment or adjunctive therapy of certain ear conditions caused by or associated with neomycin-susceptible organisms and/or allergy.
   2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.