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 21749-850-89, 21749-850-90
Set ID 36803a5b-3075-5d5b-e054-00144ff8d46c
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

    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 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 promptly and thoroughly with water
    • do not use routineely 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 product (6 full strokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers
    • a separate nail cleaner may be used
    • rinse thoroughly
    • wash for an additional 3 minutes with 5 mL of product (6 full strokes) and rinse under running water and dry thoroughly

    Healthcare personnel handwash:

    • wet hands with water
    • dispense 5 ml of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and 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

  • PRINCIPAL DISPLAY PANEL

    PROVON® Antimicrobial Foam Handwash

    Chlorhexidine Gluconate 2% Solution - Antiseptic

    GOJOADXFLBLC

    8842-643-F

    ADX Front

    PROVON® Antimicrobial Foam Handwash

    Chlorhexidine Gluconate 2% Solution - Antiseptic

    GOJOLTXFLBLC

    1922-643-F

    LTX Front

    PACKAGE LABEL. SECONDARY DISPLAY PANEL

    NDC 21749-850-90

    Brought to you by GOJO

    PROVON® BRAND

    Antimicrobial Foam Handwash with 2% CHG

    Chlorhexidine Gluconate 2% Solution - Antiseptic

    Distributed by:

    GOJO Industries, Inc.

    Akron, OH 44309

    800-321-9647 • 330-255-6000

    www.GOJO.com

    ©2019. GOJO Industries, Inc.

    All rights reserved.

    Made in U.S.A.

    GOJOADXBLBLB

    8842-642-B

    42 fl oz (1250 mL)

    ADX Back PDP

    ADX Back Drug Facts 1

    ADX Back Drug Facts 2

    NDC 21749-850-89

    Brought to you by GOJO

    PROVON® BRAND

    Antimicrobial Foam Handwash with 2% CHG

    Chlorhexidine Gluconate 2% Solution - Antiseptic

    Distributed by:

    GOJO Industries, Inc.

    Akron, OH 44309

    800-321-9647 • 330-255-6000

    www.GOJO.com

    ©2019. GOJO Industries, Inc.

    All rights reserved.

    Made in the USA with U.S. and foreign components

    GOJOLTXBLBLB

    1922-642-B

    40.5 fl oz (1200 mL)

    LTX Back PDP

    LTX Back Drug Facts 1

    LTX Back Drug Facts 2

  • 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:21749-850-891200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2016
    2NDC:21749-850-901250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942207/01/2016
    Labeler - Gojo Industries, Inc. (004162038)
    Registrant - Xttrium Laboratories, Inc. (007470579)
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