3M DURAPREP SURGICAL - iodine povacrylex and isopropyl alcohol solution
3M Health Care

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3M™ DuraPrep™ Surgical Solution

Drug Facts

Active ingredients

Iodine povacrylex (0.7% available iodine)

Isopropyl alcohol, 74% w/w

Purpose

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:

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

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:

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).

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

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 Applicator Label

Principal Display Panel – 6 mL Case Label

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

Made in U.S.A. for

3M Health Care

St. Paul, MN 55144-1000

1-800-228-3957

3M and DuraPrep are trademarks of 3M

Solution:

US Patent 4,584,192

34-8704-4733-0

Principal Display Panel – 6 mL Case Label

Principal Display Panel – 26 mL Applicator Label

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

34-8703-7990-5

Principal Display Panel – 26 mL Applicator Label

Principal Display Panel – 26 mL Case Label

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

Made in U.S.A. for

3M Health Care

St. Paul, MN

55144-1000

1-800-228-3957

Solution:

US Patent 4,584,192

34-8704-4731-4

3M and DuraPrep are trademarks of 3M

Principal Display Panel – 26 mL Case Label

3M DURAPREP SURGICAL
iodine povacrylex and isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	17518-011
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Iodine povacrylex (Iodine povacrylex)	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
alcohol
water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	17518-011-08	20 APPLICATOR In 1 CASE	contains a APPLICATOR
1		26 mL In 1 APPLICATOR	This package is contained within the CASE (17518-011-08)
2	17518-011-07	50 APPLICATOR In 1 CASE	contains a APPLICATOR
2		6 mL In 1 APPLICATOR	This package is contained within the CASE (17518-011-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021586	09/29/2006

Labeler - 3M Health Care (006173082)

Revised: 12/20103M Health Care