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

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 7, 2021

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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin zinc (bacitracin 400 units)

    Neomycin sulfate (neomycin 3.5mg)

    Polymyxin B sulfate (polymyxin B 5,000 units)

    Purpose

    First aid antibiotic

  • Use

    • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • Warnings

    For external use only.

    Do not use

    • in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    • deep or punture wounds • animal bites • serious burns.

    Stop use and ask a doctor if

    • the condition persists or gets worse • a rash or other allergic reaction develops.

    Keep out of reach of children.

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

  • Inactive ingredients

    Mineral oil, petrolatum, purified water

  • Package Labeling:

    Antibiotic Application

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC APPLICATION 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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 B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0013-010 in 1 KIT08/06/2016
    10.9 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/06/2016
    Labeler - CMC Group, Inc. (117201448)
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