Label: ANTIMICROBIAL SKIN CLEANSER- chlorhexidine gluconate 2% solution liquid

  • NDC Code(s): 21749-106-32, 21749-106-89
  • Packager: Gojo Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 18, 2019

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  • Drug Facts

  • Active ingredient

    Chlorhexidine gluconate 2% solution

  • Purpose

    Antiseptic

  • Uses

    • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
    • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • Warnings

    For external use only

    Allergy alert:

    This product may cause a severe alleric reaction. Symptoms may include:

    • wheezing/difficulty breathting
    • 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 permenant eye injury if permitted to enter and remain in the eye or may cause deafness when instilled through the middle ear through perforated eardrums.
    • if solution should contact these areas, rinse out promptly 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 under 2 months of age. These products may cause irritation or chemical burns.

    Healthcare personnel handwash:

    • wet hands with water
    • dispense 5 mL of product (4 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds
    • dry thoroughly

    Surgical hand scrub:

    • wet hands and forearms with water
    • scrub for 3 minutes with 5 mL of product (4 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
    • a seperate nail cleaner may be used
    • rinse thoroughly
    • wash for an additional 3 minutes with 5 mL of product (4 full strokes) and rinse under running water and dry thoroughly

  • OTHER SAFETY INFORMATION

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

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

  • Questions or comments?

    call 1-800-321-9647 Monday through Friday 8:30 AM to 5:00 PM

  • PRINCIPAL DISPLAY PANEL

    NDC 21749-106-89

    Chlorhexidine Gluconate 2% Solution

    Antimicrobial SKin Cleanser

    Distributed by:

    Gojo Industries, Inc.

    Akron, OH 44309

    330-255-6000

    www.gojo.com

    FMX

    NDC 21749-106-89

    Chlorhexidine Gluconate 2% Solution

    Antimicrobial SKin Cleanser

    Distributed by:

    Gojo Industries, Inc.

    Akron, OH 44309

    330-255-6000

    www.gojo.com

    TFX

    Back GOJO 1

    Back GOJO 2

    Back GOJO 3

    NDC 21749-106-32

    PROVON BRAND

    Antimicrobial Skin Cleanser

    Chlorhexidine Gluconate

    2% Solution

    Antiseptic

    Distributed by:

    GOJO Industries, Inc.

    Akron, OH 44309

    Questions?

    Tel. 800-321-9647

    *330-255-6000

    www.GOJO.com

    ©2018. All rights reserved.

    2PROV32BTLLBL

    4104-12

    Net Contents: 32 fl oz (1qt) (946 mL)

    PROV32 PDP

    PROV32 Drug Facts 1

    PROV32 Drug Facts 2

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL SKIN CLEANSER 
    chlorhexidine gluconate 2% solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-106
    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
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-106-891200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2008
    2NDC:21749-106-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942203/01/2008
    Labeler - Gojo Industries, Inc. (004162038)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(21749-106)
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