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

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

NDC 21749-225-53
Set ID 6e0f3d2f-7834-68a0-e053-2991aa0ab453
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

    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 allergy reaction occurs, stop use and seek madical help right away.

  • Do not use

    If you are allerigic 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 routinely if you have wounds which invlove more than the superficial layers of the skin

  • Stop use and ask doctor if

    irritation, sensitization, or allerigic 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 two months of age. These products may cuase irritation or chemical burns

    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

    rinse and dry thoroughly

    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 seperate 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

  • Other information

    store at 20-25ºC (68-77ºF)

    avoid excessive heat above 40ºC (104ºF)

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    NDC 21749-225-53

    Purell

    FOAM HANDWASH

    Chlorhexidine Gluconate 2% Solution - Antiseptic

    Broad spectrum kill

    Gentle on hands

    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.

    Reorder 5742-06

    GOJOBLUE18LBLB

    5742-643

    GOJOBLUE18 PDP

    GOJOBLUE18 Drug Facts

  • 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
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-225-53535 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2018
    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)

Related Drugs