WATER-JEL 3-IN-1 ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [WATER-JEL TECHNOLOGIES]

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  • WATER-JEL 3-IN-1 ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [WATER-JEL TECHNOLOGIES]

WATER-JEL 3-IN-1 ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [WATER-JEL TECHNOLOGIES]
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NDC 59898-740-01, 59898-740-02, 59898-740-03, 59898-740-34, 59898-740-36, 59898-740-38
Set ID d5fcaffd-af38-4285-a79c-6df7424c76fa
Category HUMAN OTC DRUG LABEL
Packager Water-Jel Technologies
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • Active ingredients (each gram contains)

    Bacitracin zinc 400 units

    Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

    Polymyxin B sulfate 5000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    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

    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 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 15 o to 25 oC (59 o to 77 oF)
    • tamper evident sealed packets
    • 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?

    800-275-3433 

    info@waterjel.com   www.waterjel.com

  • Principal Display Panel

    image of pdpEnter section text here

  • INGREDIENTS AND APPEARANCE
    WATER-JEL 3-IN-1 ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-740
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN417.8 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5322.8 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-740-02144 in 1 BOX, UNIT-DOSE03/30/2010
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:59898-740-0325 in 1 BOX, UNIT-DOSE03/30/2010
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:59898-740-011728 in 1 CARTON03/30/2010
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:59898-740-381728 in 1 CARTON03/30/2010
    40.5 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:59898-740-340.9 g in 1 PACKET; Type 0: Not a Combination Product03/30/2010
    6NDC:59898-740-360.5 g in 1 PACKET; Type 0: Not a Combination Product03/30/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/30/2010
    Labeler - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-740)
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