Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP

Company: VetOne

For Veterinary Use Only

Sterile Ophthalmic Ointment

ANADA 200-553, Approved by FDA

Description

Each gram contains: polymyxin B sulfate 10,000 units, bacitracin zinc 400 units, neomycin sulfate 5 mg (equivalent to 3.5 mg neomycin base) in a white petrolatum base, q.s.

ACTIONS: Polymyxin B is one of a group of closely related substances produced by various strains of Bacillus polymyxa. The activity of polymyxin B is sharply restricted to gram-negative bacteria. Neomycin, isolated from Streptomyces fradiae, has antibacterial activity in vitro against a wide range of gram-negative and gram-positive organisms. Bacitracin, an antibiotic substance derived from cultures of Bacillus subtilis (Tracy), exerts antibacterial action in vitro against a variety of gram-positive and a few gram-negative organisms.

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP Indications

This product is indicated for the treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to organisms susceptible to one or more of the antibiotics contained in the ointment.

Laboratory tests should be conducted including in vitro culturing and susceptibility tests on samples collected prior to treatment.

Precautions

If irritation develops discontinue treatment with this drug. If there is no response to treatment in 2 to 3 days, discontinue treatment and re-evaluate diagnosis. Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

Care should be taken not to contaminate the applicator tip during administration of the preparation.

Adverse Reactions

Adverse reactions, such as itching, burning, or inflammation may occur in animals sensitive to this product.

Dosage and Administration

Properly cleanse area to be treated. Foreign bodies, crusted exudates and debris should be carefully removed. Express a small quantity of ointment into the conjunctival sac beneath the lower eyelid three or four times daily. After application, hold the eyelids shut for a short time so that a thin film of ointment covers the cornea.

How Supplied

NDC 13985-758-35 Tube of 3.5 g (1/8 oz) with ophthalmic tip.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temp].

See crimp of tube for Lot Number and Expiration Date.

KEEP OUT OF REACH OF CHILDREN.

Not for Human Use.

FOR OPHTHALMIC USE ONLY

Restricted Drug - Use Only as Directed.

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP Caution

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Warning: Serious hypersensitivity (anaphylactic) reactions have been reported in cats within 4 hours of application of antibiotic ophthalmic preparations. Some of these reactions have resulted in death.

Distributed by: MWI, Boise, ID 83705

www.VetOne.net

MWNB00N

Rev. 04/18

CPN: 1315294.0