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

  • NDC Code(s): 61010-4400-1
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each gram)

    Bacitracin Zinc (400 units)

    Neomycin Sulfate 5mg (3.5mg Neomycin)

    Polymyxin B Sulfate (5000 units)

  • Purpose

    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 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 havedeep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor ifthe 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 (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

    White Petrolatum

  • Principal Display Panel – 1 oz. Tube Label

    Safetec®

    Triple Antibiotic Ointment

    First Aid Infection Protection

    Net Wt. 1 oz. (28.4g)

    Reorder No. 53207

    Manufactured for: Safetec of America, Inc.

    Buffalo, NY 14215 | 1-800-456-7077

    Made in IndiaKD/503

    Principal Display Panel – Tube Panel
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 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:61010-4400-128.4 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00411/01/2019
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-4400)
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