Label: BACITRACIN ZINC- first aid antibiotic ointment

  • NDC Code(s): 21922-091-04, 21922-091-05
  • Packager: Encube Ethicals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 4, 2025

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  • ACTIVE INGREDIENT(S)

    (in each gram)
    Bacitracin zinc, USP 500 units ............. First aid antibiotic

  • PURPOSE

    First aid antibiotic 

  • USE(S)

    First Aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • WARNINGS

    For External Use Only.

  • DO NOT USE

    • if you are allergic to any of the ingredients
    • in the eyes 
    • over large areas of the body
  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • deep or puncture wounds 
    • animal bites
    • serious burns 
  • STOP USE AND ASK DOCTOR IF

    • you need to use longer than one week 
    • condition persist or gets worse 
    • rash or other allergic reaction develops 
  • KEEP OUT OF REACH OF CHILDREN

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

  • 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
  • OTHER INFORMATION

    • store at 150C to 300C (590F to 860F)
    • before using any medication, read all label directions. Keep carton, it contains important information. 
  • INACTIVE INGREDIENTS

    white petrolatum

  • QUESTIONS OR COMMENTS?

    Call 1-833-285-4151


    Mfg. Lic. No.: 362 


    Manufactured by:
    Encube Ethicals Pvt. Ltd.
    Plot no. C-1, Madkaim
    Industrial Estate, Madkaim,
    Post: Mardol, Ponda,
    Goa - 403 404, India.



    Distributed by:
    Encube Ethicals, Inc.
    200 Meredith Drive,
    Suite 202, Durham,
    NC 27713, USA

  • PRINCIPAL DISPLAY PANEL

    BACITRACIN ZINC OINTMENT, USP 

    First aid antibiotic

    NET WT. 0.5 OZ (14 g)

    carton-14g

    BACITRACIN ZINC OINTMENT, USP 

    First aid antibiotic

    NET WT. 1 OZ (28 g)

    carton-28g

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    first aid antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21922-091
    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
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21922-091-041 in 1 CARTON03/13/2025
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:21922-091-051 in 1 CARTON03/13/2025
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00403/13/2025
    Labeler - Encube Ethicals, Inc. (116982244)
    Registrant - Encube Ethicals Private Limited (915834105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Encube Ethicals Private Limited725076298analysis(21922-091) , label(21922-091) , manufacture(21922-091) , pack(21922-091)
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