f Neomycin, prednisolone, and tetracaine otic suspension.
21 C.F.R. § 524.1484f
in effectEffective: 2024-07-01(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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026