Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment, USP is supplied in a 3.5 g tube with an ophthalmic tip. NDC 24208-780-55 – 3.5 g tube Caution: Federal law prohibits dispensing without a prescription. FOR TOPICAL OPHTHALMIC USE DO NOT Storage: Store between 15°C to 25°C (59°F to 77°F). Keep tightly closed when not in use. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: 01/2023 9113603 (Folded) 9113703 (Flat); PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-780-55 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP (Sterile) FOR TOPICAL OPHTHALMIC USE ONLY {eye image} Rx only Net Wt. 3.5 g (1/8 oz) BAUSCH + LOMB 9758802 carton
- HOW SUPPLIED Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment, USP is supplied in a 3.5 g tube with an ophthalmic tip. NDC 24208-780-55 – 3.5 g tube Caution: Federal law prohibits dispensing without a prescription. FOR TOPICAL OPHTHALMIC USE DO NOT Storage: Store between 15°C to 25°C (59°F to 77°F). Keep tightly closed when not in use. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: 01/2023 9113603 (Folded) 9113703 (Flat)
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-780-55 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP (Sterile) FOR TOPICAL OPHTHALMIC USE ONLY {eye image} Rx only Net Wt. 3.5 g (1/8 oz) BAUSCH + LOMB 9758802 carton
Overview
Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment, USP is a sterile antimicrobial ointment for topical ophthalmic use. Each gram contains Actives: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and bacitracin zinc equivalent to 400 bacitracin units; Inactives: white petrolatum and mineral oil. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are: Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula for bacitracin A is: A picture containing text, diagram, font, map Description automatically generated A picture containing text, font, white, receipt Description automatically generated A picture containing line, diagram, text, font Description automatically generated
Indications & Usage
Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
Dosage & Administration
Apply the ointment topically into the conjunctival sac of the affected eye(s) every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
Warnings & Precautions
WARNINGS NOT FOR INJECTION INTO THE EYE Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter ( see PRECAUTIONS: General ).
Contraindications
Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.
Adverse Reactions
Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema ( see WARNINGS ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. Local irritation on instillation has also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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