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

  • NDC Code(s): 83165-005-00
  • Packager: Hubei Fanjian Medical Product Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 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

  • Uses

    first aid to help decrease the risk of infection in minor 

    • cuts • scrapes • burns

  • Warnings

    For external use only

    Do not use

    • for more than 1 week unless directed by a doctor

    • in the eyes

    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds • serious burns • animal bites

    Stop use and ask a doctor if 

    • 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 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
    FIRST AID ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83165-005
    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:83165-005-001 in 1 PACKAGE01/01/2023
    10.9 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00401/01/2023
    Labeler - Hubei Fanjian Medical Product Co.,Ltd (846385590)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hubei Fanjian Medical Product Co.,Ltd846385590manufacture(83165-005)
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