- SPL UNCLASSIFIED SECTION
- DESCRIPTION:
- ACTION:
- INDICATIONS:
- CONTRAINDICATIONS:
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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.
- ADVERSE REACTIONS:
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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.
- HOW SUPPLIED:
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - Carton Label
Rx only
BACITRACIN OPHTHALMIC
OINTMENT USP
STERILECONTAINS: 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 CHILDRENSee crimp of tube for Lot No. & Exp. Date
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INGREDIENTS AND APPEARANCE
BACITRACIN
bacitracin ointmentProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0649(NDC:48102-007-35) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-0649-1 1 in 1 CARTON 1 3.5 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA061212 04/29/1994 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel