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Bacitracin Zinc and Polymyxin B Sulfate (Rebel Distributors Corp.)

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OINTMENT 3.5 g in 1 TUBE (21695-156-35) Label Information

Complete Bacitracin Zinc and Polymyxin B Sulfate Information

  • SPL UNCLASSIFIED SECTION

    Rx only


  • DESCRIPTION

    Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is a sterile antimicrobial ointment for ophthalmic use.

    Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula for bacitracin A is:

    Chemical Structure

    bacitracin A

    Polymyxin B Sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

    Chemical Structure

    Each gram contains: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.


  • CLINICAL PHARMACOLOGY

    Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species.

    Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.


  • INDICATIONS AND USAGE

    For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.


  • CONTRAINDICATIONS

    This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.


  • WARNINGS

    Ophthalmic ointments may retard corneal healing.


  • PRECAUTIONS

    As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.


  • DOSAGE AND ADMINISTRATION

    Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.


  • HOW SUPPLIED

    Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.

    NDC 21695-156-35

    STORAGE

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


  • SPL UNCLASSIFIED SECTION

    Manufactured By: Akorn, Inc.
    Lake Forest, IL 60045

    Repackaged by:

    Rebel Distributors Corp.

    Thousand Oaks, CA 91320


  • Principal Display Panel

    Bacitracin Zinc/Polymyxin B 500/10,000 Units


  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC AND POLYMYXIN B SULFATE 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-156(NDC:17478-238)
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc 500 [USP'U]  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate 10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    mineral oil (UNII: T5L8T28FGP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21695-156-35 3.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064028 01/30/1995
    Labeler - Rebel Distributors Corp. (118802834)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distributors Corp. 118802834 RELABEL, REPACK