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

  • NDC Code(s): 0168-0021-09, 0168-0021-31, 0168-0021-35
  • Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL

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 February 12, 2013

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  • 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 burns

    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 store at room temperature

    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)

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

    NDC 0168-0021-35

    Fougera ®

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

    First Aid Antibiotic

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz CARTON
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

    NDC 0168-0021-09

    Fougera®

    First Aid Antibiotic NET WT 0.9 g (1/32 Oz)

    Double Antibiotic Ointment
    (Bacitracin Zinc and Polymyxin B
    Sulfate Ointment USP)
    Uses: First aid to help prevent infection in
    • minor cuts • scrapes • burns

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON

    NDC 0168-0021-09

    Fougera ®

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

    First Aid Antibiotic

    This product available in tubes at pharmacy.

    1 GROSS
    NET WT 0.9 g (1/32 Oz) FOILPACS
    ®

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON - >NET WT. 0.9 g (1/32 Oz)
  • INGREDIENTS AND APPEARANCE
    DOUBLE ANTIBIOTIC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0021-351 in 1 CARTON
    114.17 g in 1 TUBE
    2NDC:0168-0021-311 in 1 CARTON
    228.35 g in 1 TUBE
    3NDC:0168-0021-091 in 1 CARTON
    30.9 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/06/2010
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)