BACITRACIN OINTMENT [WATER-JEL TECHNOLOGIES]

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BACITRACIN OINTMENT [WATER-JEL TECHNOLOGIES]
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NDC 59898-720-01, 59898-720-02, 59898-720-03, 59898-720-36
Set ID 412928a1-3708-4fa8-99c5-aaa2b079cf6e
Category HUMAN OTC DRUG LABEL
Packager Water-Jel Technologies
Generic Name
Product Class
Product Number
Application Number PART333B
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  • Active ingredient

    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 or 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 if you have

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

    Stop use and ask a doctor if

    • the 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
    • apply a small amount of the 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

    • store at room temperature
    • do not use any opened or torn packets
    • you may report a serious adverse reaction to this product to 800-275-3433
  • Inactive ingredient

    petrolatum

  • Questions or comments?

    1-800-276-3433 info@waterjel.com www.waterjel.com
    Manufactured by Water-Jel Technologies, Inc

    50 Broad St., Carlstadt NJ 07072 USA

  • Principal Display Panel

    BAUD

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-720
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-720-02144 in 1 BOX, UNIT-DOSE11/07/2010
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:59898-720-0325 in 1 BOX, UNIT-DOSE11/07/2010
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:59898-720-011728 in 1 CARTON11/07/2010
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:59898-720-360.9 g in 1 PACKET; Type 0: Not a Combination Product11/07/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/07/2010
    Labeler - Water-Jel Technologies (155522589)
    Registrant - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-720)
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