{"adverse_reactions":["ADVERSE REACTIONS: Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued. 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."],"contraindications":["CONTRAINDICATIONS: This product should not be used in patients with a history of hypersensitivity to Bacitracin."],"description":["DESCRIPTION: Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye."],"effective_time":"20120905","how_supplied":["HOW SUPPLIED: NDC 48102-007-13 3 - 1 g sterile tamper evident tubes with ophthalmic tip. NDC 48102-007-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip. Store at 20°-25° C (68°-77° F) (See USP Controlled room temperature)."],"id":"3461a765-e885-49af-b23a-e23de479de3f","indications_and_usage":["INDICATIONS: For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms."],"mechanism_of_action":["ACTION: The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 3x1 g tubes, Carton Label NDC 48102-007-13 Rx only BACITRACIN OPHTHALMIC OINTMENT USP, 500 units/g STERILE 3 x 1 g tubes Sterile Ophthalmic Ointment Weighing 1 gram each USUAL DOSAGE: Apply 1 to 3 times daily. See package insert for full prescribing information. EACH GRAM CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil. Keep tightly closed. Store at 20°-25° C (68°-77° F) (See USP Controlled room temperature). Keep out of reach of children. Bacitracin Ophthalmic Ointment USP, 500 units/g - 3 x 1 g tubes carton label","PRINCIPAL DISPLAY PANEL - 1 g tube, Immediate Container Label NDC 48102-007-11 STERILE Rx only BACITRACIN OPHTHALMIC OINTMENT USP 500 units/g NET WT 1 gm Bacitracin Ophthalmic Ointment, USP 500 units/g - 1 g tube label","PRINCIPAL DISPLAY PANEL - 3.5 g tube, Carton Label NDC 48102-007-35 Rx only BACITRACIN OPHTHALMIC OINTMENT USP STERILE CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil. NET WT 3.5 g (1/8 Oz) USUAL DOSAGE: 3 applications daily. See insert for complete information. KEEP TIGHTLY CLOSED STORE AT ROOM TEMPERATURE KEEP OUT OF REACH OF CHILDREN See crimp of tube for Lot No. & Exp. Date Bacitracin Carton Label","PRINCIPAL DISPLAY PANEL - 3.5 g tube, Immediate Container Label NDC 48102-007-35 BACITRACIN OPHTHALMIC OINTMENT USP STERILE Rx only USUAL DOSAGE: 3 applications daily. See insert for complete information. WARNING: Keep out of reach of children. See crimp for Lot No. and Exp. Date CONTAINS: 500 units of Bacitracin per gram, White Petrolatum, Mineral Oil. NET WT 3.5 g (1/8 Oz) KEEP TIGHTLY CLOSED STORE AT ROOM TEMPERATURE Bacitracin Container Label"],"precautions":["PRECAUTIONS: Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted."],"set_id":"b2983ec7-5f63-4909-891b-92214d3a637f","spl_product_data_elements":["BACITRACIN BACITRACIN BACITRACIN BACITRACIN MINERAL OIL PETROLATUM"],"spl_unclassified_section":["Rx Only","Manufactured for: Fera Pharmaceuticals, LLC Locust Valley, NY 11560 PF00735A R1111 Fera logo"],"version":"3"}