Label: BD E-Z SCRUB 107- chlorhexidine gluconate solution

  • NDC Code(s): 17271-107-03
  • Packager: Becton Dickinson and Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated 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 11/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    4% Chlorhexidine gluconate w/v

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  • Purpose

    Antiseptic

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  • Use

    preoperative cleaning of healthcare personnel arms and hands.

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  • Warnings

    For external use only.

    Do not use

    • as a preoperative skin preparation of the face or head
    • in eyes, ears and mouth
    • if you have a sensitivity to chlorhexidine gluconate or its components.

    When using this product

    • avoid contact with meninges
    • chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforated ear drums
    • chlorhexidine gluconate solution has been reported to cause serious and permanent eye injury when it has been permitted to enter and remain in the eye during surgical procedures
    • if chlorhexidine gluconate solution should contact these areas, rinse out promptly and thoroughly with water.

    Stop use and ask a doctor if adverse reactions occur. Irritation, sensitization and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas.

    Keep out of reach of children. If swallowed, gets in eye or ear, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • wet hands and forearms to the elbows with warm water
    • use nail cleaner and apply scrub solution from sponge side
    • work up lather
    • scrub nails, cuticles and interdigital spaces thoroughly for 3 minutes with brush side and hands and forearms with the sponge side
    • rinse with warm water
    • repeat scrub for 3 more minutes, use the sponge side only. Add water as necessary to produce the desired level of suds.
    • rinse hands and arms thoroughly
    • dry thoroughly
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  • Other information

    • avoid excessive heat 40°C (104°F)
    • discard after single use.
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  • Inactive ingredients

    FD&C red #40, hydrochloric acid, lauramide DEA, nonoxynol-12, peg-6000 distearate, peg-75 lanolin, purified water USP, sodium hydroxide

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  • Questions? 1-800-453-4538 Monday to Friday, 8 a.m. to 5 p.m. MST
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Carton Label

    BD
    BD E-Z Scrub™ 107

    Surgical Scrub Brush/Sponge
    and Nail Cleaner with
    4% Chlorhexidine Gluconate

    4% CHG
    CONTAINS:
    30

    NOTE: SEE BACK PANEL
    FOR EASY INSTRUCTIONS

    REF 371073
    NDC 17271-107-03
    U.S. Patent 5, 164, 107

    Principal Display Panel – Carton Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Package Label

    BD E-Z Scrub™ 107
    Surgical Scrub Brush/Sponge
    4% CHG
    NDC 17271-107-03
    REF 371073

    Principal Display Panel – Package Label
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  • INGREDIENTS AND APPEARANCE
    BD E-Z SCRUB 107 
    chlorhexidine gluconate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17271-107
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    chlorhexidine gluconate (chlorhexidine) chlorhexidine gluconate 40 g  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    hydrochloric acid  
    lauric diethanolamide  
    nonoxynol-12  
    POLYETHYLENE GLYCOL 6000  
    peg-75 lanolin  
    water  
    sodium hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17271-107-03 10 in 1 BOX
    1 30 in 1 CARTON
    1 18 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA072525 09/10/2001
    Labeler - Becton Dickinson and Company (124987988)
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