TOPCARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [TOPCO ASSOCIATES LLC]

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  • TOPCARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [TOPCO ASSOCIATES LLC]

TOPCARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [TOPCO ASSOCIATES LLC]
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NDC 36800-056-24
Set ID 0fc0dbc6-ca1d-42be-8016-68e64f119706
Category HUMAN OTC DRUG LABEL
Packager Topco Associates LLC
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc USP 500 unitsFirst aid antibiotic
    Neomycin sulfate USP 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate USP 10,000 unitsFirst aid antibiotic
    Pramoxine HCl USP 10 mgExternal analgesic
  • Uses

    first aid to help prevent infection and for the 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
    • 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

    Stop use and ask a doctor if

    • you need to use longer 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

    • 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

    • To open: unscrew cap, pull tab to remove foil seal
    • store at 20° to 25°C (68° to 77°F)
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredient

    white petrolatum

  • Questions?

    Call 1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    TopCare®
    health™

    NDC 36800-056-24

    MAXIMUM STRENGTH

    Triple Antibiotic Ointment
    + Pain Relief
    BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCL
    First Aid Antibiotic / Pain Relieving Ointment

    • OUR PHARMACISTS
    RECOMMEND •

    NET WT 1 OZ (28.4 g)

    Principal Display Panel - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOPCARE   TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-056
    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:36800-056-241 in 1 CARTON03/31/2012
    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 - Topco Associates LLC (006935977)
    Registrant - Taro Pharmaceuticals U.S.A., Inc (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-056)
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