Label: MAJOR BACITRACIN- bacitracin ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

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  • Active Ingredient

    Bacitracin 500 Units per gram

  • Purpose

    First Aid Antibiotic

  • Uses

    First Aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • Warnings

    For External Use Only.

  • Do Not Use

    • in eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
  • Ask Doctor before Use

    if you have deep or puncture wounds, animal bites or serious burns.

  • Stop Use and Ask Doctor if

    • The condition persists or gets worse
    • A rash or allergic reaction develops
  • Directions

    • Clean the affected area and dry thoroughly
    • Apply a small amount of the 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
  • Inactive Ingredients

    mineral oil, petrolatum

  • Questions

    Call 1-888-296-9067

  • Storage Information

    Store at 15° to 25°C (59° to 77°F).

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Other Information

    Distributed By:

    MAJOR® PHARMACEUTICALS

    Indianapolis, IN 46268

    Call (800) 616-2471

    www.majorpharmaceuticals.com

    This product is not manufactured or distributed by Woodward Pharma woner of the registered trademark Baciguent®

  • Packaging

    701378 Major Bacitracin Ointment 0.9g 144ct 120723 CDER

  • INGREDIENTS AND APPEARANCE
    MAJOR BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7402-67144 in 1 CARTON03/08/2024
    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 DrugM00403/08/2024
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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