Home > Drugs A-Z > Bacitracin Zinc and Polymyxin B Sulfate

Bacitracin Zinc and Polymyxin B Sulfate (H.J. Harkins Company, Inc.)

Available Formats

Dosage Form Package Information Links
OINTMENT 28.34 g in 1 TUBE (52959-054-07) Label Information
OINTMENT 14.17 g in 1 TUBE (52959-054-03) Label Information
OINTMENT 144 g in 1 TUBE (52959-054-44) Label Information

Complete Bacitracin Zinc and Polymyxin B Sulfate Information

  • Drug Facts


  • Active ingredients (in each gram)

    Bacitracin Zinc (equal to 500 bacitracin units)

    Polymyxin B Sulfate (equal to 10,000 polymyxin B units)


  • Purpose

    Antibiotic

    Antibiotic

    Uses first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burn

  • Warnings


  • For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients

    Ask a doctor before use in case of deep or puncture wounds, animal bites or serious bums

    When using this product do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • if 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.

    Directions

    • clean the 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

    Other information

    • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal store at room temperature
    • see crimp of tube for Lot No. and Exp. date

    Inactive ingredient white petrolatum

    Questions or comments ? call toll free 1-800-645-9833


  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

    Fougera®

    NDC 0168-0021-35

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

    Repacked by:
    H.J. Harkins Company, Inc.
    513 Sandydale Drive
    Nipomo, CA 93444

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC AND POLYMYXIN B SULFATE 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-054(NDC:0168-0021)
    Route of Administration TOPICAL
    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 1000 [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:52959-054-03 14.17 g in 1 TUBE
    2 NDC:52959-054-07 28.34 g in 1 TUBE
    3 NDC:52959-054-44 144 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 01/06/2010
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    Name Address ID/FEI Business Operations
    Nycomed US Inc. 174491316 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Nycomed US Inc. 043838424 ANALYSIS, MANUFACTURE