Label: BACITRACIN ZINC AND POLYMYXIN B SULFATE - bacitracin zinc and polymyxin b sulfate ointment

  • 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 August 29, 2011

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

  • Drug Facts
  • Active ingredients (in each gram)

    Bacitracin Zinc (equal to 500 bacitracin units)

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

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  • Purpose

    Antibiotic

    Antibiotic

    Uses first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burn
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  • 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

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  • 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
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  • 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
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