BACITRACIN — bacitracin ointment
Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.
MECHANISM OF 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.
INDICATIONS & USAGE
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
This product should not be used in patients with a history of hypersensitivity to Bacitracin.
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 to BACITRACIN
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.
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.
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).
Fera Pharmaceuticals, LLC
Locust Valley, NY 11560
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
- BACITRACIN 500[iU] in 1g
- MINERAL OIL
PACKAGING: 3.5 g in 1 TUBE
| BACITRACIN |
|Labeler — REMEDYREPACK INC. (829572556)|
Revised: 06/2013 REMEDYREPACK INC.
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