Label: BACITRACIN ZINC ointment

  • NDC Code(s): 69396-163-09
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2025

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

  • 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

    • 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
  • ASK DOCTOR BEFORE USE IF

    you have deep or puncture wounds, aniimal bites or serious burns.

  • Keep out of reach of children

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

  • Inactive Ingredients

    Mineral oil, white petrolatum, paraffin

  • 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

  • PRINCIPAL DISPLAY PANEL

    1013SL GLOBE BACITRACIN OINTMENT 0.9G 144CT REV01 060425-NT CDER

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-163
    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
    PARAFFIN (UNII: I9O0E3H2ZE)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-163-09144 in 1 CARTON06/05/2025
    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 DrugM00406/05/2025
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)