Label: WATER-JEL 3-IN-1 ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

  • NDC Code(s): 59898-740-01, 59898-740-02, 59898-740-03, 59898-740-34, view more
    59898-740-36, 59898-740-38
  • Packager: Water-Jel Technologies
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 16, 2017

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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

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  • 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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