Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% solution

  • NDC Code(s): 0404-1061-01, 0404-1061-32
  • Packager: Henry Schein, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 15, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Chlorhexidine gluconate 4% solution

  • Purpose

    Antiseptic

  • 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
    • skin wound and general skin cleansing
  • Warnings

    For external use only

    Allergy alert: This product may cause a severe allergic reaction. Symptoms may include:

    • wheezing/difficuly breathing
    • shock
    • facial swelling
    • hives
    • rash

    If an allergic reaction occurs, stop use and seek medical help right away.

  • Do not use

    • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
    • in contact wth the meninges
    • in the gential area
  • When using this product

    • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 advised by a health care provider
  • 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.

  • 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 forwarms with 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 seperate 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 15 seconds
    • rinse and dry thoroughly

    Skin wound and general skin cleansing:

    • thoroughly 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
  • Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

  • Questions or comments?

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

  • OTHER SAFETY INFORMATION

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

    WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

    Rev 7/2018

  • Active ingredient

    Chlorhexidine gluconate 4% solution

  • Purpose

    Antiseptic

  • 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
    • skin wound and general skin cleansing
  • Warnings

    For external use only

    Allergy alert: This product may cause a severe allergic reaction. Symptoms may include:

    • wheezing/difficulty breathing
    • shock
    • facial swelling
    • hives
    • rash

    If an allergic reaction occurs, stop use and seek medical help right away.

  • Do not use

    • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
    • 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 permitted to enter and remain in the eye or may cuase 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 advised by a health care provider
  • Stop use and ask a doctor if

    irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition

  • Keeo out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 with 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 seperate 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 15 seconds
    • rinse and dry thoroughly

    Skin wound and general skin cleansing:

    • thoroughly 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
  • Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
  • Inactive ingredients

    cocamide DE, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

  • Questions or comments?

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

  • OTHER SAFETY INFORMATION

    Laundering/Cleaning Instructions:

    Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

    WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

    Rev 11/2018

  • PRINCIPAL DISPLAY PANEL

    431-0032

    Henry Schein®

    Maxiclens

    Antiseptic Skin Cleasner

    (Chlorhexidine Gluconate 4%)

    FOR EXTERNAL USE ONLY

    Net Contents

    32 fl oz (1qt)(946-mL)

    Made in U.S.A

    Distributed By

    HENRY SCHEIN INC.

    135 Duryea Road

    Melville, NY 11747 USA

    4MAX32BTLLBL

  • Content of Labeling

    Content of Labeling

    Drug Facts 1

    Drug Facts 2

  • Package label and principal display panel

    NDC 0404-1061-01

    431-0099

    HENRY SCHEIN ®

    Maxiclens

    Antiseptic Skin Cleanser

    (Chlorhexidine Gluconate 4%)

    FOR EXTERNAL USE ONLY

    Net Contents

    128 fl oz (1 gal) (3.785 L)

    Made in U.S.A.

    Distributed By

    HENRY SCHEIN INC.

    135 Duryea Road

    Melville, NY 11747 USA

    4MAX1GBTLLBL

    1-gallon PDP

    1-gallon drug facts

    1-gallon drug facts 2

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    chlorhexidine gluconate 4% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-1061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-1061-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/02/2003
    2NDC:0404-1061-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/02/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912504/02/2003
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories007470579manufacture(0404-1061)