Label: BD E-Z SCRUB- chlorhexidine gluconate solution

  • NDC Code(s): 17271-506-02
  • Packager: Becton Dickinson and Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    chlorhexidine gluconate 2% solution

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  • Purpose

    surgical hand scrub

    healthcare personnel handwash

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  • 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
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  • Warnings

    For external use only

    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredients
    • in contact with meninges
    • in the genital area
    • as a preoperative skin preparation of the head or face
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  • When using this product

    • keep out of eyes, ears, and mouth
    • may cause serious and permanent eye injury if placed or kept in the eye during surgical procedures 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
    • wounds that involve more than the superficial layers of the skin should not be routinely treated
    • repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population 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.

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  • 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 solution (4 full strokes) and a wet brush paying close attention to the nails, cuticles, and interdigital space
    • a separate nail cleaner may be used
    • rinse thoroughly
    • wash for an additional 3 minutes with 5 ml of solution (4 full strokes) and rinse under running water
    • dry thoroughly

    Healthcare personnel handwash:

    • wet hands with water
    • dispense 5 ml of solution (4 full strokes) into cupped hands, wash in a vigorous manner for 15 seconds, and rinse under running water
    • dry thoroughly
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  • Other information

    • store at 20-25° C (68-77° F)
    • avoid excessive heat above 40° C (104° F)
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  • Inactive ingredients

    citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

    Questions or comments?

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

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Box Label

    NDC 17271-506-02

    BD E-Z Scrub

    Chlorhexidine
    Gluconate 2% Solution
    Antiseptic

    REF 372416
    Foreign Patents and patents Pending.
    U.S. Patent 6,427,875

    Chlorhexidine Gluconate

    32 FL. OZ (946 ml)

    Principal Display Panel – Box Label
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  • INGREDIENTS AND APPEARANCE
    BD E-Z SCRUB 
    chlorhexidine gluconate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17271-506
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    chlorhexidine gluconate (chlorhexidine) chlorhexidine gluconate 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    citric acid monohydrate  
    coco diethanolamide  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)  
    ISOPROPYL ALCOHOL  
    lauramine oxide  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17271-506-02 6 in 1 BOX
    1 946 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019422 04/01/2001
    Labeler - Becton Dickinson and Company (124987988)
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