Label: SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- polymyxin b sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride ointment

  • NDC Code(s): 49348-600-72
  • Packager: Strategic Sourcing Services LLC
  • 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 November 27, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purposes
    Bacitracin 500 unitsFirst aid antibiotic
    Neomycin 3.5 mgFirst aid antibiotic
    Polymyxin B 10,000 unitsFirst aid antibiotic
    Pramoxine HCl 10 mgTopical pain reliever
  • Uses

    first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use if you are allergic to any of the ingredients

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not use in the eyes
    • do not apply over large areas of the body

    Stop use and ask a doctor if

    • you need to use for 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

    • unscrew cap and pull tab to remove foil seal
    • adults and children 2 years of age and older:
      • 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 a doctor
  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredient

    white petrolatum

  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson
    One Post Street
    San Francisco, CA 94104

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    sunmark™

    triple antibiotic ointment

    plus pain reliever

    polymyxin B sulfate • bacitracin zinc
    neomycin sulfate • pramoxine hydrochloride

    First Aid Antibiotic

    MAXIMUM STRENGTH

    NET WT 1 OZ (28.4 g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK   TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
    polymyxin b sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  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 B10000 [iU]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-600-721 in 1 CARTON02/13/2013
    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 finalpart333B03/31/2012
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-600)
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