Label: BACITRACIN ZINC ointment

  • NDC Code(s): 69396-104-09, 69396-104-25
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Active Ingredient

    Bacitracin Zinc 500 Units

  • 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
  • Stop Use and Ask Doctor if

    • Before use in case of deep puncture wounds, animal bites or serious burns
    • 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
  • Keep out of reach of children

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

  • Inactive Ingredients

    Mineral oil, white petrolatum

  • Questions

    Call 1-888-296-9067

    Fax: 1-888-878-3609

    Online: www.trifecta-pharma.com

    Reorder No. 1013SL

  • Storage Information

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

  • Other Information

    Distributed By:

    Trifecta Pharmaceuticals USA®

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • Packaging

    1013SL GLOBE BACITRACIN OINTMENT 0.9G 144CT 060523 CDER_

  • PRINCIPAL DISPLAY PANEL

    1014SL GLOBE BACITRACIN OINTMENT 0.9G 25CT 121422 CDER

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-104
    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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-104-09144 in 1 CARTON04/21/2020
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69396-104-2525 in 1 CARTON03/14/2022
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00404/21/2020
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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