Label: SCRUB CARE- chlorhexidine gluconate solution 

  • NDC Code(s): 57613-007-25
  • Packager: Productos Urologos de Mexico, S.A. de C.V.
  • 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 09/13

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

  • Active ingredient

    Chlorhexidine gluconate solution 4%

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  • Purpose

    Antiseptic

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  • Use

    Surgical Hand Scrub:Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

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  • Warnings

    For external use only.

    Do not use

    if you are allergic to chlorhexidine gluconate or any other ingredients 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 or allowed to remain
    if contact occurs, rinse with cold water right away
    do not use routinely if you have wounds which involve more than the superficial layers of the skin
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  • Stop use and ask a doctor if

    irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. If condition persists for more than 72 hours, consult a doctor.

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  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

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  • Directions

    wet hands and forearms to the elbows
    clean under nails with pick provided
    wet sponge and squeeze to work up lather
    scrub thoroughly for 3 minutes. Use the brush side to clean the nails, cuticles, and interdigital spaces between the fingers and the sponge side to scrub the hands and forearms.
    rinse thoroughly
    scrub for an additional 3 minutes using the sponge side only. Wet sponge and squeeze to produce additional lather.
    rinse thoroughly and dry with a sterile towel
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  • Other information

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

    Cocamide DEA, Fragrance POFL 147, Glucono-Delta-Lactone, Hydroxyethylcellulose, Isopropyl Alcohol, Lauramine Oxide, PEG-75 Lanolin, Purified Water, Tridecyl Alcohol

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  • Questions?

    Call: 1-800-523-0502 (Mon.-Fri. 8 AM-5 PM CST)

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  • Principal Display Panel

    Cat. 4458A

    Scrub Care® Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub

    NDC 57613-007-25

    CareFusion

    Vernon Hills, IL 60061 USA

    Made in Mexico

    27-10012

    Pouch Lidding

    Lidding

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  • INGREDIENTS AND APPEARANCE
    SCRUB CARE 
    chlorhexidine gluconate solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57613-007
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 4 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLUCONOLACTONE  
    ISOPROPYL ALCOHOL  
    WATER  
    LAURAMINE OXIDE  
    COCO DIETHANOLAMIDE  
    PEG-75 LANOLIN  
    TRIDECYL ALCOHOL  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57613-007-25 30 in 1 CARTON
    1 25 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA019793 12/01/1998
    Labeler - Productos Urologos de Mexico, S.A. de C.V. (812552219)
    Registrant - CareFusion 2200, Inc (832696038)
    Establishment
    Name Address ID/FEI Business Operations
    Productos Urologos de Mexico, S.A. de C.V. 812552219 LABEL(57613-007), PACK(57613-007)
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