Label: FIRST AID ANTIBIOTIC BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE- bacitracin zinc, neomycin sulfate, polymyxin b sulfate gel

  • NDC Code(s): 84219-001-00
  • Packager: M-star (Hubei) Health&Care Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2024

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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 ingredients
    • longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    • deep or puncture 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 ingredient:

    Mineral oil, petrolatum, purified water

  • Question?

    +1(855)924-2182

  • Package Labelling:

    Label2.jpg

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTIBIOTIC BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84219-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  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:84219-001-000.5 g in 1 POUCH; Type 0: Not a Combination Product05/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00405/15/2024
    Labeler - M-star (Hubei) Health&Care Products Co., Ltd. (409376382)
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