§ 524.1484f. Neomycin, prednisolone, and tetracaine otic suspension.
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/us/cfr/t21/s§ 524.1484f·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]