Label: HIBISTAT- chlorhexidine gluconate and isopropyl alcohol solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 19, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Chlorhexidine gluconate solution 0.5% w/wAntiseptic
    Isopropyl alcohol, 70% w/wAntiseptic
  • Use

    • Healthcare Personnel Hand Antiseptic helps reduce bacteria that potentially can cause disease.
  • Warnings

    For external use only

    Flammable: keep away from fire or flame.

    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
    • as a patient preoperative skin preparation (especially on the head or face)
    • in contact with the meninges
    • in the genital area

    When using this product

    • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures, or may cause deafness when instilled in the middle ear through perforated eardrums.
    • if contact occurs in any of these areas, rinse with cold water right away

    Stop use and ask a doctor if

    • irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • rub hands vigorously with the towelette for about 15 seconds
    • pay particular attention to nails and interdigital spaces
    • no watering or toweling are necessary
  • Inactive ingredients

    castor oil, glycerin, purified water

  • Questions?

    1-800-843-8497

  • PRINCIPAL DISPLAY PANEL - 5mL Wipe Packet

    NDC 0234-0587-17

    HIBISTAT®
    (0.5% Chlorhexidine
    Gluconate solution
    70% isopropyl alcohol w/w)

    Healthcare Personnel Hand Antiseptic

    HIBISTAT® provides rapid bactericidal action and has
    a persistent antimicrobial effect against a wide range
    of microorganisms.

    WARNING: For external use only
    Flammable:     Keep away from fire or flame.
    FOR PROFESSIONAL USE ONLY.

    MÖLNLYCKE®
    HEALTH CARE

    1 Hand Antiseptic Wipe (5mL)

    Distributed by Mölnlycke Health Care US, LLC.,
    Norcross GA 30092

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    HIBISTAT 
    chlorhexidine gluconate and isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0234-0587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorhexidine gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine gluconate0.525 g  in 5 mL
    Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302) Isopropyl alcohol70 g  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Castor Oil (UNII: D5340Y2I9G)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0234-0587-1750 in 1 CARTON
    15 mL in 1 PACKET
    2NDC:0234-0587-2715 in 1 CARTON
    25 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01830005/23/1980
    Labeler - Mölnlycke Health Care US, LLC (165301032)
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