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BACITRACIN (Rebel Distributors Corp)

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OINTMENT 1 TUBE in 1 CARTON (42254-003-35) > 3.5 g in 1 TUBE Label Information

Complete BACITRACIN Information

  • SPL UNCLASSIFIED SECTION

    Rx Only


  • 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.


  • SPL UNCLASSIFIED SECTION

    Fera logo

    Manufactured for:

    Fera Pharmaceuticals, LLC
    Locust Valley, NY 11560

    FPBC00N                   Rev. 08/09

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320


  • PRINCIPAL DISPLAY PANEL

    Bacitracin 500 Units


  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-003(NDC:48102-007)
    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:42254-003-35 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 01/11/2010
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp 118802834 RELABEL, REPACK