Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution

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

Drug Label Information

Updated January 11, 2016

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  • Active Ingredient

    Chlorhexidine gluconate 4% Solution

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  • Purpose

    Antiseptic

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  • Uses

    • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
    • 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

    • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

    Surgical hand scrub:

    • wet hands and forearms under running water
    • scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
    • a separate nail cleaner may be used
    • rinse thoroughly
    • wash for an additional 3 minutes with 5 mL of product and rinse under running water
    • dry thoroughly

    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 and 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 product necessary to cover the skin or wound area and wash gently
    • rinse again 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, Monday through Friday 8:00 AM to 4:30 PM CST

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  • OTHER SAFETY INFORMATION

    Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

    Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

    *This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

    4HM08BTLLBLA

    Distributed by McKesson

    One Post Street, San Francisco, CA 94104

    Money Back Guarantee

    www.healthmart.com/healthmartbrand

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  • Principal Display

    NDC 37205-595-34

    Leader ®

    Compare to Hibiclens® active ingredient*

    Antiseptic Skin Cleanser

    (CHLORHEXIDINE GLUCONATE 4% SOLUTION)

    ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

    FOR EXTERNAL USE ONLY

    DYE FREE

    8FL OZ (237mL)

    012

    34

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  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    chlorhexidine gluconate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37205-595
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-595-34 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    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. (007470579)
    Establishment
    Name Address ID/FEI Business Operations
    Xttrium Laboratories, Inc. 007470579 manufacture(37205-595)
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