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

PURELL ANTIMICROBIAL FOAM (CHLORHEXIDINE GLUCONATE 2% SOLUTION) LIQUID [GOJO INDUSTRIES, INC.]
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NDC 21749-225-56, 21749-225-57, 21749-225-58
Set ID 6c7e63c2-428b-2be2-e053-2a91aa0a6af3
Category HUMAN OTC DRUG LABEL
Packager GOJO Industries, Inc.
Generic Name
Product Class
Product Number
Application Number NDA019422
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    chlorhexidine gluconate 2% solution

  • Purpose

    Antiseptic

  • Uses

    healthare personnel handwash: helps reduce bacteria that can potentially 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 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 permenant 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.

    Healthcare personnel handwash:

    wet hands with water

    dispense 5mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds

    rinse and dry throughly

    Surgical hand scrub:

    wet hands and forearms with water

    scrub for 3 minutes with 5mL of product (6 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 5mL of product (6 full strokes) and rinse under running water and dry throughly

  • Other information

    store at 20-25°C (68-77°F)

    avoid excessive heat above 40°C (104°F)

  • Inactive ingredients

    citric acid, comide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide. purified water

  • PRINCIPAL DISPLAY PANEL

    Purell

    Healthcare

    FOAM HANDWASH

    2% CHG

    Antimicrobial Foam

    GOJOCSFLBLA

    7887-641-F

    CS Front

    NDC 21749-225-58

    Purell

    Healthcare FOAM HANDWASH 2% CHG

    Antimicrobial Foam

    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.

    GOJOCS4BLBLA

    5181-642-ES-B

    42 fl oz (1250 mL)

    CS4 Label

    NDC 21749-225-57

    Purell

    Healthcare FOAM HANDWASH 2% CHG

    Antimicrobial Foam

    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.

    GOJOCS6BLBLA

    6581-642-ES-B

    40.5 FL OZ (1200 mL)

    CS6 Label

    NDC 21749-225-56

    Purell

    Healthcare FOAM HANDWASH 2% CHG

    Antimicrobial Foam

    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

    GOJOCS8BLBLA

    7881-641-ES-B

    40.5 FL OZ (1200 mL)

    CS8 Label

  • PRINCIPAL DISPLAY PANEL

    HEALTHCARE

    PURELL

    FOAM

    HANDWASH

    CHLORHEXIDINE GLUCONATE

    2% SOLUTION - ANTISEPTIC

    40.5 fl oz (1200 mL)

    GOJOESFLBL

    7781-640-F

    GOJO ES front PDP

    GOJO ES front drug facts

    NDC 21749-225-64

    Purell

    Healthcare

    FOAM HANDWASH

    2% CHG Antimicrobial Foam

    40.5 fl oz (1200 mL)

    GOJOES4BLBL

    5081-640-B

    GOJO ES4

    NDC 21749-225-68

    Purell

    Healthcare

    FOAM HANDWASH

    2% CHG Antimicrobial Foam

    40.5 fl oz (1200 mL)

    GOJOES8BLBL

    7781-640-B

    GOJO ES8

  • INGREDIENTS AND APPEARANCE
    PURELL ANTIMICROBIAL FOAM 
    chlorhexidine gluconate 2% solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-225
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-225-581250 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    2NDC:21749-225-571200 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    3NDC:21749-225-561200 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    4NDC:21749-225-641200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2019
    5NDC:21749-225-681200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942202/01/2018
    Labeler - GOJO Industries, Inc. (004162038)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(21749-225)

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