Label: ANTISEPTIC SKIN CLEANSER- 2% chlorhexidine gluconate solution solution

  • NDC Code(s): 46122-659-36
  • Packager: AmerisourceBergen Drug Corporation
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 6, 2020

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

  • Active ingredient

    Chlorhexidine gluconate 2% 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
  • Warnings

    For external use only

    Allergy alert: This product may cause 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 are allergic to chlorhexidine gluconate or any other ingredient in this product
  • 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 promply and thoroughly with water
    • do not use routinely if you have wounds which involve more than the superficial layers of the 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.

  • 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 for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
    • scrub for 1.5 minutes with about 8 mL of product (5 full pumps) with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers.
    • rinse thoroughly under running water for 30 seconds
    • wash for an additional 1.5 minutes with 8 mL (5 full pumps) of product and rinse under running water for 30 seconds
    • dry thoroughly

    Healthcare personnel handwash:

    • wet hands with water
    • dispense about 5 mL of product (3 full pumps) into cupped hands and wash in a vigorous manner for 15 seconds
    • rinse and dry thoroughly
  • Other information

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

    citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

  • 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.

  • PRINCIPAL DISPLAY PANEL

    GOOD NEIGHBOR PHARMACY®

    NDC 46122-659-36

    Advanced Antibacterial Hand Soap

    CHLORHEXIDINE GLUCONATE 2% SOLUTION

    ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

    • Used by healthcare professionals
    • Clincally proven to reduce bacteria on skin
    • Paraben & phthalate free

    8.5 FL OZ (250 mL)

    2GNP85FBTLLBL

    2GNP85 PDP

    2GNP85 DF1

    2GNP85 DF2

    2GNP85 DF3

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC SKIN CLEANSER 
    2% chlorhexidine gluconate solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-659
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-659-36250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942210/01/2020
    Labeler - AmerisourceBergen Drug Corporation (007914906)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(46122-659)