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

Drug Label Information

Updated 11/11

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  • 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 Item Code (Source) NDC:17271-107
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    chlorhexidine gluconate (UNII: MOR84MUD8E) (chlorhexidine - UNII:R4KO0DY52L) chlorhexidine gluconate 40 g  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    hydrochloric acid (UNII: QTT17582CB)  
    lauric diethanolamide (UNII: I29I2VHG38)  
    nonoxynol-12 (UNII: 6NR43D77O6)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    peg-75 lanolin (UNII: 09179OX7TB)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    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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