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

  • NDC Code(s): 50814-077-01
  • Packager: GFA Production(Xiamen) Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2023

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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin zinc (bacitracin 400 units)

    Neomycin sulfate (neomycin 3.5 mg)

    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 bums

    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:

    Label02

  • INGREDIENTS AND APPEARANCE
    GENUINE FIRST AID ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-077
    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) NEOMYCIN3.5 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:50814-077-010.9 g in 1 TUBE; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00411/01/2023
    Labeler - GFA Production(Xiamen) Co.,Ltd (421256261)
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