Label: BD E-Z SCRUB- chlorhexidine gluconate solution

  • NDC Code(s): 0116-0505-01, 0116-0505-02
  • Packager: Xttrium Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 12, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    chlorhexidine gluconate 4% 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

    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 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.

    Surgical hand scrub:

    • wet hands and forearms with water
    • scrub for 3 minutes with about 2.0 cubic inches of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
    • a separate nail cleaner may be used
    • rinse thoroughly
    • wash for an additional 3 minutes with 2.0 cubic inches of product and rinse under running water
    • dry thoroughly

    Healthcare personnel handwash:

    • wet hands with water
    • dispense 1.5 cubic inches of product 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

    cocamide DEA, fragrance, glucono-delta-lactone, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

  • Questions or comments?

    call 1-800-453-4538 Monday through Friday 8 AM to 5 PM EST

  • OTHER SAFETY INFORMATION

    WARNING: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine) which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

  • PRINCIPAL DISPLAY PANEL

    NDC 17271-505-02

    BD E-Z Scrub

    Chlorhexidine Gluconate 4% Solution Antiseptic

    REF 372412

    Foreign Patents and Patents Pending

    U.S. Patent 6,427,875

    CHLORHEXIDINE GLUCONATE

    32 fl oz (946 mL)

    4BD32SQ

    NDC 17271-505-01

    BD E-Z Scrub

    Chlorhexidine Gluconate 4% Solution Antiseptic

    REF 372402

    Foreign Patents and Patents Pending

    U.S. Patents 6,053,369 6,308,866

    Chlorhexidine Gluconate

    32 fl oz (946 ml)

    4BD32RND

  • INGREDIENTS AND APPEARANCE
    BD E-Z SCRUB 
    chlorhexidine gluconate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0505
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE40 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-0505-01946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
    2NDC:0116-0505-02946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01912701/01/2006
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-0505)
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