21 CFR 524.1484f
§ 524.1484f Neomycin, prednisolone, and tetracaine otic suspension.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1484f, § 524.1484f Neomycin, prednisolone, and tetracaine otic suspension, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87635
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.