21 C.F.R. § 524.1484a Neomycin sulfate ophthalmic ointment.
Title 21 - Food and Drugs
(a) Specifications. Each gram of the ointment contains 5 milligrams of neomycin sulfate equivalent in activity to 3.5 milligrams of neomycin base. (b) Sponsor. See No. 017030 in §510.600(c) of this chapter. (c) Conditions of use. (1) The drug is intended for use in dogs and cats for the treatment of superficial ocular bacterial infections limited to the conjunctival or the anterior segment of the eye. (2) The drug is applied four times each day. (3) The drug is applied by inserting the tip of the tube beneath the lower lid and by expressing a small quantity of ointment into the conjunctival sac. The tip of the tube should not come in contact with the eye surface. (4) Severe infections should be supplemented by systemic therapy. (5) Prolonged administration of the drug may permit overgrowth of organisms that are not susceptible to neomycin. If new infections due to bacteria or fungi appear during therapy, appropriate measures should be taken. (6) 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 44 FR 49666, Aug. 24, 1979]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1484a Neomycin sulfate ophthalmic ointment.
