Label: TRIPLE ANTIBIOTIC ointment

  • NDC Code(s): 58228-2009-1, 58228-2009-2
  • Packager: ProStat First Aid
  • 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 March 21, 2023

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  • Active Ingredient (in each gram)

    Bacitracin Zinc 400 Units

  • Active Ingredient

    Neomycin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)

  • Active Ingredient (in each gram)

    Polymyxin B Sulfate 5000 Units

  • Purpose

    First Aid Antibiotic

  • Use(s)

    First aid to help prevent infection in minor cuts, scrapes, and burns

  • Warnings

    For External Use Only

    Do not use

    • In the eyes or apply 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, or 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 (1-800-222-1222) right away.

  • Directions

    Clean the affected area. Apply a small amount of the 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 between 15º-30ºC (59º-86ºF)

    • Tamper evident. Do not use if packet is torn, cut, or opened.

  • Inactive Ingredient

    White Petrolatum

  • Questions?

    1-888-900-2920 Monday - Friday 8AM - 4PM PST

  • Label

    PS-2009-BX-MASTERTriple Antibiotic Ointment

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    triple antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-2009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58228-2009-21800 in 1 CASE04/10/2023
    1NDC:58228-2009-125 in 1 BOX
    10.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/10/2023
    Labeler - ProStat First Aid (061263699)
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