Label: TRIPLE 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 July 5, 2022

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  • Active Ingerdients (in each gram)

    Bacitracin Zinc USP 400 Units

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

    Polymixin B Sulfate USP 5,000 Units

  • Purpose

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

  • DO NOT USE

    Do not use:

    • If you are allergic to any of the ingredients
    • In the eyes
    • Over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • Deep or puncture wounds
    • Animal bites
    • Serious burns

    Stop use and ask a doctor if:

    • You need to use longer than 1 week
    • Condition persists or gets worse
    • Rash or other allergic reaction developes
  • KEEP OUT OF REACH OF CHILDREN

    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 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
    • Children under 2 years of age - Ask the doctor
  • Other Information

    • Store at 20-25°C (68-77°F)
    • Store away from heat
  • Inactive ingredients

    White Petrolatum

  • Questions or comments?

    Call 1-866-747-7365

  • PRINCIPAL DISPLAY PANEL

    Manufactured for : SOLA Pharmaceuticals

    Baton Rouge, LA 70810

    Triple Antibiotic


    NDC 70512-102-30


    Qty: 28.4g

    Triple

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    triple antibiotic ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-102-301 in 1 CARTON02/12/2021
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/12/2021
    Labeler - SOLA Pharmaceuticals (080121345)
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