3M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [3M HEALTH CARE]

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3M DURAPREP SURGICAL (IODINE POVACRYLEX AND ISOPROPYL ALCOHOL) SOLUTION [3M HEALTH CARE]
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NDC 17518-011-07
Set ID 22a10a54-6a04-48b3-9ec4-b26526183daf
Category HUMAN OTC DRUG LABEL
Packager 3M Company
Generic Name
Product Class
Product Number
Application Number NDA021586
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Iodine povacrylex (0.7% available iodine)

    Isopropyl alcohol, 74% w/w

  • 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
  • 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
    • 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

    Figure-Flame

    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.

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

  • 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:

    • grasp product by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever.
    • with sponge face parallel to the floor, snap lever. Allow all fluid to flow into sponge.

    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.
    • 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.

    Figure-No Pooling

    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.

      Figure-Cautery

    After Solution is Completely Dry:

    • to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all solution-stained materials are removed
    • if incise drapes are used, apply directly to dry prep. On completion of surgical procedure, removal of incise drape will remove film.
    • apply dressing following standard practices
  • 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).
  • Inactive ingredients

    ethyl alcohol, water

  • Questions?

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

  • Principal Display Panel – 6 mL Applicator Label

    3M

    STERILE EO

    NDC 17518-011-07

    Do Not Reuse

    1. SNAP

    2. PAINT, DO

    NOT SCRUB

    DuraPrep TM

    Surgical Solution

    Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)

    Patient Preoperative Skin Preparation For head, neck, and small prep areas

    Non-sterile Solution Applicator is sterile if package is intact

    REF 8635 0.2 fl oz • 6 mL

    External Use Only Professional Use Only

    Read Drug Facts Information before use.

    Made in U.S.A. by Figure 3M Health Care

    2510 Conway Ave., St. Paul, MN 55144

    1-800-228-3957 © 2015, 3M. All rights reserved.

    3M and Duraprep are trademarks of 3M.

    Principal Display Panel – 6 mL Applicator Label

  • Principal Display Panel – 6 mL Insert Label

    3M

    STERILE EO

    NDC 17518-011-07

    MAL09032040XR

    DuraPrep TM

    Surgical Solution

    Iodine Povacrylex (0.7% Available Iodine)

    and Isopropyl Alcohol (74% w/w)

    Patient Preoperative Skin Preparation

    Non-sterile Solution

    Applicator is sterile if package is intact

    For head, neck, and small prep areas

    Do Not Reuse

    Latex-Free

    Not Made With Natural Latex

    Single Use

    DuraPrep Surgical Solution is a film-forming iodophor complex. Each unit dose

    applicator contains 0.2 fl oz (6 mL) of solution which covers an approximate 8

    in x 10 in area.

    3M recommends all users participate in product in-service training prior to use.

    In-servicing is available on video, from your 3M sales representative, or at the

    3M website (www.3M.com).

    REF 8635 0.2 fl oz • 6 mL

    3M

    Made in U.S.A. by

    Figure 3M Health Care

    2510 Conway Ave

    St. Paul, MN 55144

    1-800-228-3957

    © 2015, 3M. All rights reserved.

    3M and DuraPrep are trademarks of 3M

    Principal Display Panel – 6 mL Insert Label

  • INGREDIENTS AND APPEARANCE
    3M DURAPREP SURGICAL 
    iodine povacrylex and isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17518-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Iodine Povacrylex (UNII: 6E43AWY083) (Iodine - UNII:9679TC07X4) Iodine6.02 mg  in 1 mL
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol636.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17518-011-071 in 1 CASE09/29/2006
    16 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02158609/29/2006
    Labeler - 3M Company (006173082)
    Establishment
    NameAddressID/FEIBusiness Operations
    3M Company054950670ANALYSIS(17518-011) , PACK(17518-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    3M Company078671244MANUFACTURE(17518-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    3M Company830016148ANALYSIS(17518-011)
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