BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [H.J. HARKINS COMPANY, INC.]

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BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [H.J. HARKINS COMPANY, INC.]
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NDC 52959-054-03, 52959-054-07, 52959-054-44
Set ID 715b4b25-5341-491f-98dc-dc4eb249d67b
Category HUMAN OTC DRUG LABEL
Packager H.J. Harkins Company, Inc.
Generic Name
Product Class
Product Number
Application Number PART333B
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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

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER

    Fougera®

    NDC 0168-0021-35

    Double Antibiotic Ointment
    (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

    Repacked by:
    H.J. Harkins Company, Inc.
    513 Sandydale Drive
    Nipomo, CA 93444

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC AND POLYMYXIN B SULFATE 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-054(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:52959-054-0314.17 g in 1 TUBE
    2NDC:52959-054-0728.34 g in 1 TUBE
    3NDC:52959-054-44144 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/06/2010
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nycomed US Inc.174491316MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Nycomed US Inc.043838424ANALYSIS, MANUFACTURE
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