WESTERN FAMILY BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [WESTERN FAMILY FOODS INC]

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  • WESTERN FAMILY BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [WESTERN FAMILY FOODS INC]

WESTERN FAMILY BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [WESTERN FAMILY FOODS INC]
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NDC 55312-075-02
Set ID c4b90624-4713-401f-90c8-77df632409f9
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods Inc
Generic Name
Product Class
Product Number
Application Number PART333B
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (each gram contains)

    Bacitracin Zinc 500 units

  • Purpose

    First 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 unless directed by a doctor

    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 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 ingredients

    mineral oil, white petrolatum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Western Family Foods, Inc.
    P.O. Box 4057
    Portland, OR 97208 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 28.4g Tube Carton

    Bacitracin Zinc
    OINTMENT USP

    NET WT 1 OZ
    (28.4g)

    First Aid Antibiotic Ointment

    Principal Display Panel - 28.4g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY   BACITRACIN ZINC
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    mineral oil (UNII: T5L8T28FGP)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-075-021 in 1 CARTON
    128.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/11/2006
    Labeler - Western Family Foods Inc (192166072)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(55312-075)
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