Label: TRIPLE ANTIBIOTIC- first aid antibiotic ointment

  • 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 7, 2019

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  • Active Ingredients

    Bacitracin Zinc (400 units per gram)

    Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

    Polymyxin B Sulfate (5000 units per gram)

  • Purpose

    First Aid Antibiotics

  • 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 have

    deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    the condition persists or gets worse, or if a rash or other allergic reaction develops

    If swallowed, get medical help or contact a Poison Control Center 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.

  • Inactive Ingredient

    White Petrolatum

  • Label

    1184 Triple Antibiotic NDC 67777-217-03

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    first aid antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400   in 1000 mg
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1000 mg
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000   in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-118-4072 in 1 CASE01/23/2018
    114000 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/23/2018
    Labeler - Dynarex Corporation (008124539)
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