Label: HEALTH AND .BEYOND TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 43473-050-01
  • Packager: Nantong Health & Beyond Hygienic Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 14, 2023

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  • 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 prevent infection in minor cuts, scrapes and burns

  • Warnings

    For external use only.

  • Do not use

    • in 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

    • 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

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    HEALTH AND .BEYOND TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.0035 g  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'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:43473-050-010.9 g in 1 POUCH; Type 0: Not a Combination Product07/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/14/2023
    Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
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