PROVON ANTIMICROBIAL FOAM HANDWASH (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [GOJO INDUSTRIES, INC.]

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PROVON ANTIMICROBIAL FOAM HANDWASH (CHLORHEXIDINE GLUCONATE 2%) SOLUTION [GOJO INDUSTRIES, INC.]
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NDC 21749-850-53
Set ID 365c3ac6-6c1f-594b-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Gojo Industries, Inc.
Generic Name
Product Class
Product Number
Application Number NDA019422
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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 ingredients
    • in contact with meninges
    • in the genital area
    • as a preoperative skin preparation of the head or face
  • When using this product

    • keep out of eyes, ears, and mouth
    • may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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 that 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 the underlying condition makes it necessary to reduce the bacterial population 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

    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 ® 2015

    Net Wt 18 fl oz (535 mL)

    Gojo 1022 18oz Page 3

    Gojo 1022 18oz Page 2

    Gojo 1022 18oz Page 1

  • 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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