Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid

  • NDC Code(s): 0116-0161-08, 0116-0161-15, 0116-0161-16
  • Packager: Xttrium Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 9, 2020

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  • 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
    • 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 meninges
    • in the genital area

    When using this product

    • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if pemitted to ener and remain in the eye or may cause deafness when instilled in the middle eat 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 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

    Skin wound and normal 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 1-800-925-4733

  • OTHER SAFETY INFORMATION

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

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

    ‡Walgreens Pharmacist Survey Study, November 2014

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

    Distributed by: Walgreen Co.

    200 Wilmot RD., Deerfield, IL 60015

    100% Satisfaction Guaranteed

    walgreens.com

    ©2015 Walgreen Co. Made in USA

  • Package label and principal display panel

    Walgreens

    Compare to the Hibiclens® active ingredient

    NDC 0363-1061-08

    Dye-Free

    Antiseptic Skin Cleanser

    CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER

    DYE FREE

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

    8 FL OZ (237 mL)

    WAL08 PDP

    WAL08 DF1

    WAL08 DF2

    WAL08 DF3

    VALUE SIZE

    NDC 0363-1061-16

    Walgreens

    Compare to Hibiclens® active ingredient

    Dye-Free Antiseptic Skin Cleanser

    CHLORHEXIDINE GLUCONATE 4% SOLUTION / ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER

    DYE FREE

    Skin wound & general skin cleansing

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

    16 FL OZ (473 mL)

    WAL16 PDPWAL16 DF1

    WAL16 DF2

    WAL16 DF3

  • Carton

    NDC 0363-1061-15

    Walgreens, Co.

    Chlorhexidine Gluconate 4% Solution

    Antiseptic Skin Cleansing Kit

    Distributed by:

    Xttrium Laboratories, Inc.,

    Mount Prospect, IL 60056

    4WAL15INNERCTNA

    0.5 FL OZ (15 mL)

    CTN Page 1

    CTN Page 2

    CTN Page 3

  • Lidstock

    NDC 0363-1061-15

    Walgreens, Co.

    Chlorhexidine Gluconate 4% Solution

    Antiseptic Skin Cleansing Kit

    Distributed by:

    Xttrium Laboratories, Inc.,

    Mount Prospect, IL 60056

    4WAL15LIDSTOCKA

    0.5 FL OZ (15 mL)

    LDSK

  • Packet

    NDC 0363-1061-15

    Walgreens, Co.

    Chlorhexidine Gluconate 4% Solution

    Antiseptic Skin Cleansing Convenience Kit

    Distributed by:

    Xttrium Laboratories, Inc.,

    Mount Prospect, IL 60056

    4WAL15PACKETA
    0.5 FL OZ (15 mL)

    PP Page 1

    PP Page 2

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    chlorhexidine gluconate 4% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-0161-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2011
    2NDC:0116-0161-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2011
    3NDC:0116-0161-1515 mL in 1 KIT; Type 1: Convenience Kit of Co-Package01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912505/01/2011
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-0161)
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