Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate liquid 

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

Drug Label Information

Updated 09/12

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Chlorhexidine Gluconate 4% Solution

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  • Purpose

    Antiseptic

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  • Uses

    • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
    • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
    • skin wound and general skin cleansing
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  • Warnings

    For external use only

    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredients
    • in contact with meninges
    • in the genital area
    • as a preoperative skin preparation of the head or face

    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 solution should contact these areas, rinse out promptly and thoroughly with water
    • wounds which involve more than the superficial layers of the skin should not be routinely treated
    • repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of skin

    Stop use and ask a doctor

    if irritation, sensitization or allergic reaction occurs. 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.

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  • Directions

    Healthcare personnel handwash:

    • wet hands with water
    • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
    • rinse and dry thoroughly

    Patient preoperative skin preparation:

    • apply product liberally to surgical site and swab for at lease 2 minutes
    • dry with a sterile towel
    • repeat the procedure for an additional 2 minutes and dry with a sterile towel

    Skin wound and general skin cleansing:

    • throughly rinse the area to be cleaned with water
    • apply the minimum amount of the product necessary to cover the skin and wound area and wash gently
    • rinse again and thoroughly
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  • Other information

    • store at 20-25ºC (68-77ºF)
    • avoid excessive heat above 40ºC (104ºF)
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  • Inactive ingredients

    Cocamide DEA, Fragrance, Glucono-delta-lactone, Hydroxyethylcellulose, Isopropyl Alcohol, Lauramine Oxide, PEG-75 Lanolin, Purified Water, Tridecyl Alcohol

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  • Questions or comments?

    call 1-800-587-3721 CST, Monday through Friday 8:00 AM to 4:30 PM

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  • Principal Display

    NDC 37205-595-34

    Leader®

    Antiseptic Skin Cleanser

    (Chlorhexidine Gluconate 4% Solution)

    Antiseptic/Antimicrobial Skin Cleanser

    For External Use Only

    8FL OZ (237mL)

    Distributed By Cardinal Health

    Dublin, Ohio 43017

    CIN 4530226

    www.myleader.com

    1-800-200-6313

    4LEADERBTLLBL

    All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

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  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    chlorhexidine gluconate liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:37205-595
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE 4 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    COCO DIETHANOLAMIDE  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
    ISOPROPYL ALCOHOL  
    WATER  
    TRIDECYL ALCOHOL  
    GLUCONOLACTONE  
    PEG-75 LANOLIN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-595-34 237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019125 01/01/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Xttrium Laboratories, Inc. (005140611)
    Establishment
    Name Address ID/FEI Business Operations
    Xttrium Laboratories, Inc. 005140611 manufacture(37205-595)
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