21CFR524.1484f

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