Label: DOUBLE ANTIBIOTIC- bacitracin zinc and 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 February 9, 2011

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  • Drug Facts

  • Active ingredients (in each gram)

    Bacitracin Zinc (equal to 500 bacitracin units)

    Polymyxin B Sulfate (equal to 10,000 polymyxin B units)

  • Purpose

    Antibiotic

    Antibiotic

    Uses first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burn
  • 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

    Ask a doctor before use in case of deep or puncture wounds, animal bites or serious bums

    When using this product do not use longer than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • if a 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

    • 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

    Other information

    • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal • store at room temperature
    • see crimp of tube for Lot No. and Exp. date

    Inactive ingredient white petrolatum

    Questions or comments ? call toll free 1-800-645-9833

    Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL

    Bacitracin Zinc/Polymyxin B 500 Units/10,000 Units

  • INGREDIENTS AND APPEARANCE
    DOUBLE ANTIBIOTIC 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-400(NDC:0168-0021)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc500 [USP'U]  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate1000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-400-301 in 1 CARTON
    130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/06/2010
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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