Label: BACITRACIN ZINC- bacitracin zinc ointment

  • NDC Code(s): 0168-0011-04, 0168-0011-16, 0168-0011-31, 0168-0011-35, view more
    0168-0111-09
  • 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 August 15, 2014

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

  • Active Ingredient (in each gram):

    Bacitracin Zinc (equal to 500 bacitracin units)

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  • Purpose:

    Antibiotic

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  • INDICATIONS & USAGE

    Uses:

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
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  • WARNINGS

    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 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
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  • Keep out of reach of children.

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

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  • DOSAGE & ADMINISTRATION

    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
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  • SPL UNCLASSIFIED SECTION

    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 Number and Exp. Date
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  • Inactive Ingredients

    white petrolatum

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  • SPL UNCLASSIFIED SECTION

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

    E. FOUGERA & CO.

    A division of Fougera Pharmaceuticals Inc.

    Melville, NY 11747

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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CONTAINER

    NDC 0168-0011-04

    Fougera®

    NET WT 113.4 g (4 Oz)

    FOR HOSPITAL USE ONLY

    Bacitracin Zinc Ointment USP

    First Aid Antibiotic

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CONTAINER
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz Carton

    Fougera ®

    Bacitracin Zinc
    Ointment USP

    First Aid Antibiotic

    NDC 0168-0011-04

    FOR HOSPITAL USE ONLY

    NET WT 113.4 g (4 Oz)

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz Carton
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER

    Fougera®

    First Aid Antibiotic

    Bacitracin Zinc
    Ointment USP

    Uses: First aid to help prevent infection

    in . minor cuts . scrapes . burns

    NET WT. 0.9 g (1/32 Oz)

    NDC 0168-0111-09

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

    NDC 0168-0111-09

    Fougera ®

    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
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 lb jar CONTAINER

    Fougera®

    NDC 0168-0011-16

    NET WT 453.6 g (1 lb)

    Bacitracin Zinc Ointment USP

    First Aid Antibiotic FOR HOSPITAL USE ONLY

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 lb jar CONTAINER
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  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0011
    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
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0011-35 1 in 1 CARTON
    1 14.17 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:0168-0011-31 1 in 1 CARTON
    2 28.35 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:0168-0011-04 1 in 1 CARTON
    3 113.4 g in 1 TUBE; Type 0: Not a Combination Product
    4 NDC:0168-0011-16 453.6 g in 1 JAR; 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 01/08/2010
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0111
    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
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0111-09 144 in 1 CARTON
    1 0.9 g in 1 PACKET; 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 01/08/2010
    Labeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)
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