Label: BACITRACIN- bacitracin zinc ointment

  • NDC Code(s): 69396-027-01, 69396-027-44
  • Packager: Trifecta Pharmaceuticals USA, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 7, 2024

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  • Active Ingredient

    Bacitracin Zinc 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, longer than 1 week unless directed by a doctor.

    .

  • Stop Use and Ask Doctor if

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

    Aloe vera gel, light mineral oil, white petrolatum

  • Other Information

    Store between 15º to 25ºC (59º to 77ºF)

    Lot No and Expiration Dates - please see box and tube crimp

    100% GUARANTEED

    Distributed By:

    Trifecta Pharmaceuticals USA ®

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • Keep out of reach of children

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

  • Ask

  • PRINCIPAL DISPLAY PANEL

    4028 GLOBE BACITRACIN ZINC OINTMENT 1OZ REV04 060523 CDER

  • Package Label

    402804-FBA GLOBE BACITRACIN ZINC OINTMENT 1O 4PK_BOX 030424 CDER

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-027
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-027-011 in 1 BOX03/15/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-027-444 in 1 BOX03/15/2024
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00403/15/2017
    Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)
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