Label: ANTIBIOTIC MAXIMUM STRENGTH- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 29, 2025

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  • ACTIVE INGREDIENT(S)

    Active Ingredient (in each gram)

    Bacitracin Zinc, USP            500 units

    Neomycin                             3.5mg 

    Polymyxin B Sulfate, USP   10,000 units

  • 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 A DOCTOR IF

    ■ you need to use longer than one week

    ■ condition persists 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 15°-30°C (59°-86°F). Protect from freezing.

    ■ before using any medication, read all label directions. Keep carton, it contains important information.

  • INACTIVE INGREDIENT

    white petrolatum

  • QUESTIONS OR COMMENTS?

    Call 1-833-285-4151 Monday-Friday 9AM-5PM EST

  • PRINCIPAL DISPLAY PANEL

    carton
  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC  MAXIMUM STRENGTH
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1331
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1331-011 in 1 CARTON01/29/2025
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00401/29/2025
    Labeler - Walgreens Co. (008965063)
    Registrant - Encube Ethicals Private Limited (915834105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Encube Ethicals Private Limited725076298ANALYSIS(0363-1331) , LABEL(0363-1331) , MANUFACTURE(0363-1331) , PACK(0363-1331)
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