21 C.F.R. § 524.1484f

Neomycin, prednisolone, and tetracaine otic suspension.

Last amended: 2016Year: 2026Length: 140 wordsSubsections: 3Official source

Cite as 21 C.F.R. § 524.1484f (2026)

(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]
Cross-references to the CFR
510.600
21 C.F.R. § 524.1484f: Neomycin, prednisolone, and tetracaine otic suspension. | Justis AI