SUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]

SUNMARK TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC, AND NEOMYCIN SULFATE) OINTMENT [MCKESSON]
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NDC 49348-029-72
Set ID c07d4042-c5f0-4abc-8d5f-76893eec1fc8
Category HUMAN OTC DRUG LABEL
Packager McKesson
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purposes
    Bacitracin 400 unitsFirst aid antibiotic
    Neomycin 3.5 mg First aid antibiotic
    Polymyxin B 5,000 unitsFirst aid antibiotic
  • Uses

    first aid to help prevent infection 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

    polymyxin B sulfate • bacitracin zinc • neomycin sulfate

    First Aid Antibiotic

    ORIGINAL STRENGTH

    NET WT 1 OZ (28.4 g)

    Principal Display Panel- 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK   TRIPLE ANTIBIOTIC
    polymyxin b sulfate, bacitracin zinc, and neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [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 B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-029-721 in 1 CARTON
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/14/1995
    Labeler - McKesson (177667227)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-029)