Label: SUNMARK DOUBLE ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment

  • NDC Code(s): 49348-274-72
  • 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 22, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc 500 unitsFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
  • Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week

    Ask a doctor before use

    • on deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • condition persists or gets worse
    • a rash or other allergic reaction develops

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area and dry thoroughly
    • 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
  • Other information

    • To Open: unscrew cap, pull tab to remove foil seal.
    • store at room temperature
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredient

    white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson
    One Post Street
    San Francisco, CA 94104

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    sunmark®

    double antibiotic ointment
    Bacitracin Zinc - Polymyxin B Sulfate

    FIRST AID ANTIBIOTIC

    NET WT 1 OZ (28.4 g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK   DOUBLE ANTIBIOTIC
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-274
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
    Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-274-721 in 1 CARTON12/05/1990
    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 FINALpart333B12/05/1990
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Taro Pharmaceutical U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-274)
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