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warnings
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. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General ).
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 Fera Pharmaceuticals, LLC at (414) 434-6604, Monday-Friday 9am-5pm EST or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.