BACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]

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BACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]
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NDC 51672-2075-1, 51672-2075-2
Set ID 4afdeedf-9cdf-47d6-919f-ea907fda0290
Category HUMAN OTC DRUG LABEL
Packager Taro Pharmaceuticals U.S.A., 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 20° - 25°C (68° - 77°F)
    • 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:
    Taro Pharmaceuticals
    U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    Bacitracin Zinc
    Ointment USP
    First Aid Antibiotic Ointment

    NET WT 1 oz (28.4 g)

    PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    mineral oil (UNII: T5L8T28FGP)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2075-11 in 1 CARTON05/11/2006
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51672-2075-21 in 1 CARTON05/11/2006
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B05/11/2006
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2075)
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