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

  • NDC Code(s): 61010-4400-2
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 5, 2024

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  • Active ingredients

    (in each gram)

    Bacitracin Zinc (400 units Bacitracin)

    Neomycin sulfate (3.5 mg Neomycin)

    Polymyxin B Sulfate (Polymyxin B 5000 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

    • internally
    • in eyes
    • over large areas of the body or on puncture wounds, animal bites or serious burns
    • for more than 1 week unless directed by a doctor
    • if you are allergic to any of the ingredients

    Stop use and ask a doctor if

    • a rash or allergic reaction develops
    • condition worsens or persists

    Keep out of reach of children

    If ingested, contact a Poison Control Center right away.

  • Directions

    • clean affected area
    • apply a small amount 1 to 3 times daily
    • may cover with a sterile bandage
  • Inactive ingredient

    petrolatum

  • Principal Display Panel – 28 g Tube Label

    Safetec®

    Triple
    Antibiotic
    Ointment

    First Aid
    Infection Protection

    To Help Prevent Infection
    in Minor Cuts, Scrapes,
    and Burns

    Net Wt. 1 oz. (28.4g)

    Figure
  • 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:61010-4400-228 g in 1 TUBE; Type 0: Not a Combination Product07/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00407/25/2022
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-4400)
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