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

  • NDC Code(s): 53943-987-01
  • Packager: Discount Drug Mart, Inc.
  • 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 February 17, 2023

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  • Active ingredient

    Bacitracin Zinc 400 units

    Neomycin Sulfate 3.5mg

    Polymyxin B Sulfate 5,000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large area of body

    Ask a doctor before use if you have

    • serious burns
    • deep or puncture wounds
    • animal bites

    Stop use and ask a doctor if

    • you need to use more than 1 week
    • condition persists or gets worse
    • symptoms persist for more than 1 week or clear up and occur again within a few days.
    • 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

    • adults and children 2 years of age or older:
      • clean the affected area
      • apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
      • may be covered with a sterile bandage
    • children under 2 years of age: ask a doctor
  • Other information

    • store at 15° - 25° (59° to 77°F)

  • Inactive ingredients

    Cetyl alcohol, Glycerin, Light mineral oil, Steareth-2, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

  • Package label panel

    Triple Antibiotic Ointment

    triple.carton

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-987
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  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 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARETH-2 (UNII: V56DFE46J5)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-987-011 in 1 BOX10/30/2015
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/01/2012
    Labeler - Discount Drug Mart, Inc. (047741335)
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