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Fera Logo (A3dc310a 3d75 4e1e 9f9f Ed5c77ff7bfe 01)
Manufactured for:
Fera Pharmaceuticals, LLC
Locust Valley, NY 11560
FPBC00N Rev. 08/09
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Bacitracin
FDA Label NDC 42254-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Bacitracin (NDC 42254-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, description:, action:, indications:, contraindications:, precautions:, adverse reactions:, dosage and administration:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description:
Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.
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:
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.
Contraindications:
This product should not be used in patients with a history of hypersensitivity to Bacitracin.
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:
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.
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:
3.5 g (1/8 Oz) sterile tamper proof tubes, NDC 42254-003-35.
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