Current through September 30, 2024
Section 524.1484f - Neomycin, prednisolone, and tetracaine otic suspension(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.40 FR 13873, Mar. 27, 1975, as amended at 79 FR 10971, Feb. 27, 2014