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
  • 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 September 8, 2023

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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 finalpart333B04/21/2020
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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