Label: GENUINE TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate cream

  • NDC Code(s): 50814-003-01
  • Packager: GFA Production (Xiamen) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2024

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  • Drug Facts

  • Each Gram Contains:

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg (equivalent to 3.5mg Neomycin base)

    Polymyxin B Sulfate 5000 units

    Purpose:

  • Uses:

    To help prevent infections in minor cuts, scrapes or burns.

  • Warnings:

    For external use only

    Do not use:

    in eyes, over large areas of the body, if allergic to any of the ingredients, or for more than one week unless directed by a physician.

    Stop use and consult a doctor:

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

    Keep out of reach of children:

    If ingested, contact a Poison Control Center right away.

  • Directions:

    Clean affected area, apply 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:

    Vaseline 96.41 %

    Mineral oil 2%

    Purified water.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    GENUINE TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-003
    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) NEOMYCIN5 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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50814-003-011 in 1 BOX03/23/201612/31/2025
    10.9 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00403/23/201612/31/2025
    Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)
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