Label: BACITRACIN ZINC 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 15, 2014

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  • Active Ingredient (in each gram):

    Bacitracin Zinc (equal to 500 bacitracin units)

  • Purpose:

    Antibiotic

  • INDICATIONS & USAGE

    Uses:

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • 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
  • Keep out of reach of children.

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

  • 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
  • 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
  • Inactive Ingredients

    white petrolatum

  • 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

  • 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
  • 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
  • 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
  • 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
  • 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
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0011-351 in 1 CARTON
    114.17 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0168-0011-311 in 1 CARTON
    228.35 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0168-0011-041 in 1 CARTON
    3113.4 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0168-0011-16453.6 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/08/2010
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0111-09144 in 1 CARTON
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/08/2010
    Labeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)
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