Label: PS-2261 TRIPLE ANTIBIOTIC, 0.5G ointment

  • Category: HUMAN OTC DRUG LABEL

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 Ingredient

    Bacitracin Zinc 400 units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin)

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    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 reation 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 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 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-2261 BX MASTERPS-2261 Triple Antibiotic, 0.5g

  • INGREDIENTS AND APPEARANCE
    PS-2261 TRIPLE ANTIBIOTIC, 0.5G 
    ps-2261 triple antibiotic, 0.5g ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-2261
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  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:58228-2261-11000 in 1 CARTON07/31/2023
    110 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 finalpart333B07/31/2023
    Labeler - ProStat First Aid LLC (061263699)
    Registrant - Dynarex Corporation (008124539)
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