3M DURAPREP SURGICAL- iodine povacrylex and isopropyl alcohol solution
3M Health Care
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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:
- 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
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
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.
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.
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).
Principal Display Panel – 6 mL Applicator Label
3M
STERILE EO
NDC 17518-011-07
Do Not Reuse
1. SNAP
2. PAINT, DO
NOT SCRUB
DuraPrepTM
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
External Use Only Professional Use Only
Read Drug Facts Information before use.
8635 REF 0.2 fl oz • 6 mL
34-8703-8000-2
Principal Display Panel – 6 mL Case Label
3M
STERILE EO
NDC 17518-011-07
MAL09032040XR
DuraPrepTM
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
Do Not Reuse
Latex-Free
Single Use
Sterile Contents:*
Applicator w/urethane sponge(1)
* Sterility of sterile contents guaranteed unless package is damaged
or open.
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. for
3M Health Care
St. Paul, MN 55144-1000
1-800-228-3957
© 2011 3M. All rights reserved.
3M and DuraPrep are trademarks of 3M
34-8706-8110-2
Principal Display Panel – 26 mL Applicator Label
3M
STERILE EO
NDC 17518-011-08
Do Not Reuse
1. PRESS CAP
DOWN
2. PAINT, DO
NOT SCRUB
DuraPrepTM
Surgical Solution
Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)
Patient Preoperative Skin Preparation for large prep areas below the neck
8630 REF 0.9 fl oz • 26 mL
External Use Only
Professional Use Only
Read Drug Facts Information before use.
Made in U.S.A. for 3M Health Care
St. Paul, MN 55144-1000
1-800-228-3957 All rights reserved. © 3M 2009
34-8703-7990-5
Principal Display Panel – 26 mL Case Label
3M
STERILE EO
NDC 17518-011-08
MAL09032040XR
DuraPrepTM
Surgical Solution
Iodine Povacrylex (0.7% Available Iodine)
and Isopropyl Alcohol (74% w/w)
Patient Preoperative Skin Preparation
for large prep areas below the neck
Do Not Reuse
Latex-Free
Single Use
Sterile Contents:*
Applicator w/urethane sponge(1)
Cotton-tipped swabs (2)
* Sterility of sterile contents guaranteed unless package is damaged
or open.
DuraPrep Surgical Solution is a film-forming iodophor complex. Each unit dose
applicator contains 0.9 fl oz (26 mL) of solution which covers a 15 in x 30 in area
(approximately from shoulder to groin in an average size adult).
For procedures requiring less coverage, a smaller applicator is available (8635). It
contains 0.2 fl oz (6 mL) of solution which covers an approximate 8 in x 10 in area.
Do not use more than required for the 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 8630 0.9 fl oz • 26 mL
3M
Made in U.S.A. for
3M Health Care
St. Paul, MN
55144-1000
1-800-228-3957
© 2011 3M. All rights reserved.
3M and DuraPrep are trademarks of 3M
34-8706-8113-6
| 3M DURAPREP SURGICAL
iodine povacrylex and isopropyl alcohol solution |
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| Labeler - 3M Health Care (006173082) |