Label: ACL11CH NERVE BLOCK- kit

  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated April 14, 2014

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

  • ACTIVE INGREDIENT

    CHLORAPREP ONE-STEP (chlorhexidine gluconate and isopropyl aclohol) solution
    [CareFusion 213 LLC]

    Active ingredients
    Chlorhexidine gluconate 2% w/v
    Isopropyl alcohol 70% v/v

  • PURPOSE

    Purposes
    Antiseptic
    Antiseptic
    Use
    for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

  • WARNINGS

    Warnings
    For external use only. Flammable, keep away from fire or flame.
    To reduce the risk of fire, PREP CAREFULLY:

    solution contains alcohol and gives off flammable vapors

    avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.

    do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).

    do not allow solution to pool

    remove wet materials from prep area

  • DO NOT USE

    Do not use

    on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol

    for lumbar puncture or in contact with the meninges

    on open skin wounds or as a general skin cleanser

  • WHEN USING

    When using this product

    keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

  • STOP USE

    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.

  • WHEN USING

    Directions

    use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

    use in a well ventilated area

    maximal treatment area for one applicator is approximately 4 in. x 5 in. (130 cm2)

    remove applicator from package; do not touch sponge

    hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic.

    wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin

    completely wet the treatment area with antiseptic

    dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds

    moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes

    allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.

    discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

  • STORAGE AND HANDLING

    Other information

    store between 15-30 °C (59-86 °F)

    avoid freezing and excessive heat above 40 °C (104 °F)

    the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove the tint if desired.

  • INACTIVE INGREDIENT

    Inactive ingredients

    FD&C yellow #6 dye

    USP purified water

  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    Chloraprep Solution

  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    ACL11CH

  • INGREDIENTS AND APPEARANCE
    ACL11CH NERVE BLOCK  
    regional anesthesia kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:55553-482
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:55553-482-0230 in 1 CASE
    11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 APPLICATOR 3 mL
    Part 1 of 1
    CHLORAPREP ONE-STEP  
    chlorhexidine gluconate and isopropyl alcohol solution
    Product Information
    Item Code (Source)NDC:54365-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54365-400-113 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02083208/18/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK96501701/14/2014
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Smiths Medical ASD, Inc.137835299manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    CareFusion 213 LLC830430778manufacture