Label: DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment

  • NDC Code(s): 0536-1174-20, 0536-1174-28
  • Packager: Rugby Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 27, 2019

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  • Drug Facts
  • Active ingredients (in each gram)

    Bacitracin zinc, USP 500 units
    Polymyxin B sulfate, USP 10,000 units

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  • Purpose

    First aid antibiotic

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  • Uses

    First aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
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  • Warnings

    For external use only

    Allergy alert:

    • do not use if allergic to any of the ingredients

    Do not use

    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • condition persists or gets worse
    • a rash or other allergic reaction develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • clean affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
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  • Other information

    • Store at 15° to 25°C (59° to 77°F).
    • Before using any medication, read all label directions. Keep carton, it contains important information.
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  • Inactive ingredient

    white petrolatum

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  • Questions?

    1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.

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  • Principal Display Panel

    Rugby®

    Compare to the active ingredients in Polysporin®*

    NDC 0536-1174-20

    Double Antibiotic Ointment
    (Bacitracin Zinc and Polymyxin B Sulfate Ointment, USP)

    First Aid Antibiotic

    First Aid to Help Prevent Infection in Minor Cuts, Scrapes, and Burns

    Net wt. 0.5 oz (14g)

    • Protection Against Infection
    • For Minor Cuts, Scrapes, and Burns
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  • INGREDIENTS AND APPEARANCE
    DOUBLE ANTIBIOTIC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1174
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-1174-20 1 in 1 CARTON 03/20/2019
    1 14 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:0536-1174-28 1 in 1 CARTON 03/25/2019
    2 28 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333B 03/20/2019
    Labeler - Rugby Laboratories (079246066)
    Registrant - Teva Pharmaceuticals USA, Inc. (001627975)
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