Label: BACITRACIN- bacitracin ointment

  • NDC Code(s): 0574-4022-01, 0574-4022-11, 0574-4022-13, 0574-4022-35
  • Packager: Paddock Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 12/13

If you are a consumer or patient please visit this version.

  • STERILE Rx Only
  • DESCRIPTION:

    Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.

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  • CLINICAL PHARMACOLOGY:

    The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphlococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.

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  • INDICATIONS AND USAGE:

    For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.

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  • CONTRAINDICATIONS:

    This product should not be used in patients with a history of hypersensitivity to Bacitracin.

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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.

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  • 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.

    To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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.

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  • HOW SUPPLIED:

    NDC 0574-4022-13 3 – 1 g sterile tamper evident tubes with ophthalmic tip.

    NDC 0574-4022-35 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].

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  • SPL UNCLASSIFIED SECTION

    Manufactured For

    Perrigo®

    Minneapolis, MN 55427

    0S400 RC J1

    Rev 08-13 A

    R0813

    Ini0813

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Carton (Sample Only)

    Rx Only

    NDC 0574-4022-01

    Bacitracin Ophthalmic Ointment USP

    FOR USE IN THE EYES ONLY

    NET WT 1 g

    STERILE

    Bacitracin Ophthalmic Ointment 1 g Carton
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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

    Rx Only

    NDC 0574-4022-11

    Bacitracin Ophthalmic Ointment, USP 500 units/g

    FOR USE IN THE EYES ONLY

    NET WT 1 g

    STERILE

    Bacitracin Ophthalmic Ointment 1 g Label
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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3 – 1 g Tube Carton

    Rx Only

    NDC 0574-4022-13

    Bacitracin Ophthalmic Ointment USP, 500 units/g

    3 – 1 g tubes

    Sterile Ophthalmic Ointment

    FOR USE IN THE EYES ONLY

    Weighing 1 gram each

    Bacitracin Ophthalmic Ointment 3-1 g Tubes Carton
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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

    Rx Only

    NDC 0574-4022-11

    Bacitracin Ophthalmic Ointment, USP 500 units/g

    FOR USE IN THE EYES ONLY

    NET WT 1 g

    STERILE

    Bacitracin Ophthalmic Ointment 1 g Label
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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Carton

    Rx Only

    NDC 0574-4022-35

    Bacitracin Ophthalmic Ointment USP

    NET WT 3.5 g (1/8 oz)

    STERILE

    Bacitracin Ophthalmic Ointment 3.5 g Carton
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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3.5 g Label

    Rx Only

    NDC 0574-4022-35

    Bacitracin Ophthalmic Ointment USP

    NET WT 3.5 g (1/8 oz)

    STERILE

    Bacitracin Ophthalmic Ointment 3.5 g Label
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  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0574-4022
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN (BACITRACIN) BACITRACIN 500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM  
    MINERAL OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0574-4022-01 1 in 1 CARTON
    1 NDC:0574-4022-11 1 g in 1 TUBE
    2 NDC:0574-4022-13 3 in 1 CARTON
    2 NDC:0574-4022-11 1 g in 1 TUBE
    3 NDC:0574-4022-35 1 in 1 CARTON
    3 3.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA061212 03/10/2014
    Labeler - Paddock Laboratories, LLC (967694121)
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