Label: PROVON ANTIMICROBIAL FOAM HANDWASH- chlorhexidine gluconate 2% solution

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

Drug Label Information

Updated December 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    chlorhexidine gluconate 2% solution

  • Purpose

    surgical hand scrub

    healthcare personnel handwash

  • 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

    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredient in this product
  • ​Allergy alert:

    This product may cause a serious 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.

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

    Healthcare personnel handwash:

    • wet hands with water
    • dispense 5 ml of solution (4 full strokes) into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
    • dry thoroughly
  • Other information

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

    citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

    Questions or comments?

    call 1-800-321-9647 Monday through Friday 8 AM to 5 PM MST

  • PRINCIPAL DISPLAY PANEL

    PDPDrug Facts

    NDC 21749-850-53

    Chlorhexidine Gluconate 2% Solution

    Antiseptic Foam Handwash

    Distributed by:

    Gojo Industries, Inc.

    Akron, OH 60085 USA

    330-255-6000

    www.gojo.com

    GOJO18BTLLBL

    Gojo ® 2018

    Net Wt 18 fl oz (535 mL)

  • INGREDIENTS AND APPEARANCE
    PROVON ANTIMICROBIAL FOAM HANDWASH 
    chlorhexidine gluconate 2% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-850
    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
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-850-53535 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942205/01/2016
    Labeler - Gojo Industries, Inc. (004162038)
    Registrant - Xttrium Laboratories, Inc. (007470579)
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