Label: TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b sulfate 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 April 25, 2012

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  • ACTIVE INGREDIENTS

    (in each gram)

    Bacitracin zinc, USP 400 units

    Neomycin sulfate, USP 3.5 mg

    Polymyxin B sulfate, USP 5,000 units

  • PURPOSE

    First aid antibiotic

  • USES

    Helps prevent infection in

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    For external  use only

    Allergy alert:

    • do not use if allergic to any of the ingredients
  • DO NOT USE

    • in the eyes
    • over large areas of the body
  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    • deep or puncture wounds
    • animal bites
    • serious burns
  • WHEN USING THIS PRODUCT

    • do not use longer than 1 week unless directed by a doctor
  • STOP USE AND ASK A DOCTOR IF

    • 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 affected area
    • apply a small 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 controlled room temperature 59º - 86ºF (15º - 30ºC).
    • Protect from freezing.
  • INACTIVE INGREDIENT

    White petrolatum

  • HOW SUPPLIED

    Triple Antibiotic Ointment comes in 28gr tubes

    NDC - 68788-9811-2

  • QUESTIONS?

    1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

    Relabeled By Preferred Pharmaceuticals, Inc

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Triple Antibiotic Ointment label
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9811(NDC:0472-0179)
    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 SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-9811-228 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/25/2012
    Labeler - Preferred Pharmaceuticals, Inc (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9811)
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