Label: A3441-22 SPINAL 22G QUINCKE - regional anesthesia kit   

  • NDC Code(s): 17518-011-09, 51688-9481-2
  • Packager: Smiths Medical ASD, Inc.
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 10/12

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

  • Drug Facts

    3M DURAPREP SURGICAL (iodine povacrylex and isopropyl alcohol) solution
    [3M Health Care]

    Drug Facts

    Active ingredients

    Iodine povacrylex (0.7% available iodine)

    Isopropyl alcohol, 74% w/w

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  • PURPOSE

    Purpose

    Antiseptic

    Antiseptic

    Uses

    patient preoperative skin preparation:

    • for preparation of the skin prior to surgery
    • helps reduce bacteria that potentially can cause skin infection
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  • WARNINGS

    Warnings

    For external use only. Flammable, keep away from fire or flame.

    To reduce the risk of fire, PREP CAREFULLY:

    • do not use 26-mL applicator for head and neck surgery
    • do not use on an area smaller than 8 in. x 10 in. Use a small applicator instead.
    • solution contains alcohol and gives off flammable vapors
    • 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).
    • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
    • do not allow solution to pool
    • remove solution-stained material from prep area
    flame figure 1
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  • DO NOT USE

    Do not use
    • on patients with known allergies to iodine or any other ingredients in this product
    • on open wounds, on mucous membranes, or as a general skin cleanser
    • in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism
    When using this product
    • keep out of eyes, ears, and mouth. May cause serious injury if permitted to enter and remain. If contact occurs, flush with cold water right away and contact a doctor.
    • to avoid skin injury, care should be taken when removing drapes, tapes, etc…applied over film
    • use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn

    Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. On rare occasions, use of this product has been associated with skin blistering.

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  • 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.

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  • WHEN USING

    Directions (follow all directions for use)

    • at the end of the prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available.
    Getting Patient Ready for Solution:
    • use in well-ventilated area
    • do not microwave or heat the solution applicator
    • apply to clean, completely dry, residue-free, intact skin
    • when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues.
    Activating the Applicator:
    • with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into the sponge.
    • wait for fluid level to reach indicator line of applicator barrel
    When Applying Solution:
    • DO NOT SCRUB. Paint a single, uniform application and do not reprep area.
    • do not allow solution to pool. Use sponge applicator to absorb excess solution and continue to apply a uniform coating. If solution accidentally gets outside of prep area, remove excess with gauze.
    • clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.)
    • tuck prep towels as needed under both sides of the neck to absorb excess solution. Remove towels before draping.
    • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
    • when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. Otherwise, skin may adhere to itself.
    pooling figure 1

    After Applying Solution:
    • to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Solution will turn from a shiny to a dull appearance on skin alerting the user that the solution is completely dry and no longer flammable.
    While Waiting for Solution to Completely Dry:
    • do not drape or use ignition source (e.g., cautery, laser)
    • check for pooled solution. Use sterile gauze to soak up pooled solution.

    Do not blot because it may remove solution from skin.

    • remove solution-stained materials. Replace if necessary.
    cautery figure 1


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  • STORAGE AND HANDLING

    Other information
    • store between 20-25ºC (68-77ºF)
    • avoid excessive heat above 40ºC (104ºF)
    • solution is not water soluble and may stain. Therefore, avoid contact with reusable items (basins, instruments).
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  • INACTIVE INGREDIENT

    Inactive ingredients

    ethyl alcohol, water

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  • QUESTIONS

    Questions?

    call 1-800-228-3957 (Monday to Friday 7AM – 6PM CST). www.3M.com.

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    Surgical Solution 1

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    A3441-22

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  • INGREDIENTS AND APPEARANCE
    A3441-22 SPINAL 22G QUINCKE 
    regional anesthesia kit c47916
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-9481
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:51688-9481-2 10 in 1 CASE
    1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 APPLICATOR 6 mL
    Part 1 of 1
    3M DURAPREP SURGICAL 
    iodine povacrylex and isopropyl alcohol solution
    Product Information
    Item Code (Source) NDC:17518-011
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Iodine povacrylex (Iodine) Iodine povacrylex 6.02 mg  in 1 mL
    Isopropyl alcohol (Isopropyl alcohol) Isopropyl alcohol 636.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17518-011-09 6 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021586 09/29/2006
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K965017 10/14/2006
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    Name Address ID/FEI Business Operations
    Smiths Medical ASD, Inc. 137835299 relabel, manufacture
    Establishment
    Name Address ID/FEI Business Operations
    3M Company 054236443 manufacture
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