Label: TRIPLE ANTIBIOTIC EXTRA STRENGTH- 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 July 11, 2013

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  • Active ingredients

    Drug Facts

    Bacitracin zinc 400 Units

    Neomycin sulfate 3.5 mg

    Polymyxin B sulfate 5,000 Units


  • Purpose

    First aid antibiotic

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Uses

    First aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Allergy Alert: do not use if you are allergic to any of the ingredients

    Do not use

    • in or near  eyes
    • on large areas of the body
    • Consult a doctor before use if you have
  • Directions

    • clean the affected area
    • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Other information

    • store at controlled room temperature between 68° - 77° F  (20° - 25° C)
  • Inactive ingredients

    methylparaben, mineral oil, ozocerite, petrolatum, propanediol, propylparaben


  • Product Label

    DRUGSTORE-Rx

    SMART WELLNESS

    Extra Strength

    Triple Antibiotic Ointment

    First Aid Antibiotic Ointment

    Protection against infection

    First aid treatment for minor cuts, scrapes and burns

    • Bacitracin zinc
    • Neomycin sulfate
    • Polymyxin-B sulfate



    NET WT. 0.33 OZ.  (9.4 g)

    Distributed by: PERSONAL CARE PRODUCTS, LLC
    Troy, Michigan 48084 U.S.A.

    Code No. MH/DRUGS/KD-313               Made in India


    PC TripleAB1 Label

    PC TripleAB4 Label




  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC  EXTRA STRENGTH
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2436
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 9.4 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 9.4 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 9.4 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2436-19.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/10/2013
    Labeler - Personal Care Products, Inc. (966155082)
    Registrant - Personal Care Products, Inc. (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2436)
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