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

  • NDC Code(s): 21749-416-89, 21749-416-90
  • Packager: GOJO Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 24, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • PURPOSE

    Antiseptic

  • Directions:/ Mood de Uso:

    Directions

  • Warnings/Precauciones

    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

    Para Use Externo Únicamente

    Alerta De Allergia:

    Este producto puede causar un reacción alérgica severa. Los síntomas pueden incluir:

    • sibilancias/dificultad para respirar
    • shock
    • hinchazón facial
    • urticaria
    • sarpullido

    En caso de ocurrir alguna reacción alérgica, detenga el uso y busque ayuda de inmediato

  • Do not use/No debe usante

    If you are allergic to chlorhexidine gluconate or any other ingredients

    Si es alérgico al gluconato de chlorhexidina o a cualquier otro ingrediente

  • When using this product/ Cuando use este producto

    Keep out of eyes, ear and mouth. May cause serious and permenant eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle of the ear through perforated eardrums. If solution should contact these areas, rinse out promptly and thoroughly with water.

    Evite el contacto con los ojos, oídos, y boca. Puede causar daño ocular serio y permanente si se coloca o permanece en el ojo durante procedimientos quirúrgicos o puede causar sordera si se instila en el oído medio a través de tímpano perforado. Si la solución llegara a tener contacto con estas àreas, enjuague lo más pronto posible con suficiente agua.

  • Stop use an ask a doctor if/ Mantengase fuera consulte a su médico si

    Irrititation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

    Reacciones de irritación, sensibilización o reacciones alérgicas aparecen. Estos son signos de una condicíon seria.

  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control center right away.

    En caso de ingestión, busque ayuda médica o contacte al centro de control de intoxicación de inmediato.

  • ACTIVE INGREDIENT

    Chlorhexidine Gluconate/Gluconato de chlorhexidina 20 MG/G

  • INACTIVE INGREDIENT

    Citric acid, cocamide DEA, hydroxyethlycellulose, isopropyl alcohol, lauramine oxide, aqua

  • INDICATIONS & USAGE

    Antimicrobial Handwash

  • PRINCIPAL DISPLAY PANEL

    Chlorhexidine Gluconate 2% Solution

    NDC 21749-416-89

    GOJO Industries, Inc

    Akron, OH 44309

    +330 255-6000

    www.GOJO.com

    GOJOLTXINTLLBL

    Net Wt 1200 mL

    LTX PDP

    Page 1

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    Chlorhexidine Gluconate 2% Solution

    NDC 21749-416-90

    GOJO Industries, Inc

    Akron, OH 44309

    +330 255-6000

    www.GOJO.com

    GOJOADXINTLLBL

    Net Wt 1250 mL

    ADX PDP

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL FOAM HANDWASH 
    chlorhexidine gluconate 2% solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-416
    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
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-416-891200 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2018
    2NDC:21749-416-901250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01942204/01/2018
    Labeler - GOJO Industries, Inc. (004162038)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(21749-416)