Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 61010-5603-2, 61010-5603-4
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each gram)

    Bacitracin Zinc (400 units Bacitracin)

    Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base)

    Polymyxin-B Sulfate 5000 units

  • Purposes

    First Aid Antibiotic

    First Aid Antibiotic

    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 the eyes
    • internally
    • 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:

    • in case of 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 this and all drugs out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

  • 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 (do not freeze)
    • Do Not Use any Opened or Torn Packets
  • Inactive Ingredient

    Petrolatum

  • Questions or Comments? 1-800-456-7077

    Manufactured by
    SAFETEC OF AMERICA, Inc.
    Buffalo, NY 14215 • 800-456-7077
    www.safetec.com

  • PRINCIPAL DISPLAY PANEL – 0.5g Pouch Label

    Safetec

    Triple Antibiotic Ointment™

    0.5 g (1/57 oz.)

    Safetec of America, Inc.

    Buffalo, NY 14215

    800-456-7077

    PRINCIPAL DISPLAY PANEL – 0.5g Pouch Label
  • PRINCIPAL DISPLAY PANEL – Box Label

    NDC 61010-5603-4

    Safetec

    First Aid

    Triple Antibiotic Ointment™

    First Aid to Help Prevent

    Infection In Minor Cuts,

    Scrapes, and Burns

    Reorder no. 53214

    To reorder:

    Call: 1-800-456-7077

    Fax: 716-895-2969

    Online: www.safetec.com

    PRINCIPAL DISPLAY PANEL – Box Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  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 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5603-4144 in 1 BOX03/30/2007
    1NDC:61010-5603-20.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00403/30/2007
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-5603)
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