Label: PRE-SCRUB II SURGICAL HAND SCRUB- chlorhexidine gluconate solution solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 28, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Chlorhexidine gluconate 4% Solution

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    surgical hand scrub: significantly reduces the number of micro-

    organisms on the hands and forearms prior to surgery or patient care

  • WARNINGS

    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 or allowed to remain.

    • if contact occurs, rinse with cold water right away
    • do not use routinely if you have wounds which involve more thank 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Use with care in Premature infants under 2 months of age. These

    products may cause irritation or chemical burns.

    • open package

    • wet hands and forearms to the elbows with warm water

    • clean under nails with nail pick provided. Nails should be maintained

    with a 1 millimeter free edge

    • wet sponge and squeeze to work up lather

    • scrub thoroughly for 3 minutes. Paying particular attention to the

    nails, cuticles and interdigital spaces. 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 with warm water

    • scrub for an additional 3 minutes using the sponge side

    • discard brush-sponge

    • rinse hands and forearms thoroughly and dry with a sterile towel.

  • OTHER SAFETY INFORMATION

    Other information

    • store between 20-25ºC (68-77ºF)

    •avoid freezing and excessive heat 40ºC (104ºF}

  • INACTIVE INGREDIENT

    Inactive ingredientscocamide DEA, fragrance POFL 147, glucono-delta-lactone, isopropyl alcohol 4%, lauramine oxide, PEG-75 lanolin, purified water, USP, tridecyl alcohol

  • QUESTIONS

    Questions? 800-424-5556 (Monday to Friday 8 AM – 5 PM)

  • PRINCIPAL DISPLAY PANEL

    image.jpg

  • INGREDIENTS AND APPEARANCE
    PRE-SCRUB II  SURGICAL HAND SCRUB
    chlorhexidine gluconate solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22884-8103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE1 mg  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    LANOLIN (UNII: 7EV65EAW6H)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL ALCOHOL (UNII: 8I9428H868)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22884-8103-830 in 1 CARTON03/01/1989
    1NDC:22884-8103-125 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01982203/01/1989
    Labeler - BioMed Systems, Inc. (622463388)
    Registrant - K. W. Griffen Company (622463388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bajaj Medical LLC078774921manufacture(22884-8103)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioMed Systems622463388relabel(22884-8103) , repack(22884-8103)