Label: TRIPLE ANTIBIOTIC- neomycin and polymyxin b sulfates and bacitracin zinc ointment

  • NDC Code(s): 0168-0012-09, 0168-0012-31, 0168-0012-35
  • Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
  • 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 October 22, 2012

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

  • Drug Facts
  • Active ingredients (in each gram)

     
    Neomycin Sulfate (5 mg equivalent to 3.5 mg neomycin base)
     
    Polymyxin B Sulfate (equal to 5,000 polymyxin B units)
     
    Bacitracin Zinc (equal to 400 bacitracin units)
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  • Purpose

    Antibiotic
    Antibiotic
    Antibiotic

    Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
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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 serous 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
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  • 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 0168-0012-35

    Triple Antibiotic Ointment
    (Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

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

    NDC 0168-0012-35

    Fougera ®

    Triple
    Antibiotic Ointment
    (Neomycin and Polymyxin B
    Sulfates and Bacitracin Zinc
    Ointment USP)

    The economical way to help treat
    minor cuts, scrapes, and burns.

    First Aid Antibiotic

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CARTON
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

    NDC 0168-0012-09

    Fougera®

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


    Triple Antibiotic Ointment
    (Neomycin and Polymyxin B Sulfates
    and Bacitracin Zinc Ointment USP)

    Uses: First aid to help prevent infection in
    • minor cuts • scrapes • burns

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

    NDC 0168-0012-09

    Fougera ®

    Triple
    Antibiotic Ointment
    (Neomycin and Polymyxin B Sulfates
    and Bacitracin Zinc 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) FOILPACS
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  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    neomycin and polymyxin b sulfates and bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0012
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bacitracin Zinc (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) Bacitracin Zinc 400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate 5000 [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:0168-0012-35 1 in 1 CARTON
    1 14.17 g in 1 TUBE
    2 NDC:0168-0012-31 1 in 1 CARTON
    2 28.35 g in 1 TUBE
    3 NDC:0168-0012-09 144 in 1 CARTON
    3 0.9 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 01/06/2010
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
    Establishment
    Name Address ID/FEI Business Operations
    Fougera Pharmaceuticals Inc. 043838424 ANALYSIS(0168-0012) , MANUFACTURE(0168-0012)
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