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

Antiseptic

Uses

patient preoperative skin preparation:

Warnings

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

To reduce the risk of fire, PREP CAREFULLY:

Figure

Do not use

When using this product

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)

Getting Patient Ready for Solution:

Activating the Applicator:

When Applying Solution:

Figure

After Applying Solution:

While Waiting for Solution to Completely Dry:

Do not blot because it may remove solution from skin.

Figure

After Solution is Completely Dry:

Other information

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

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

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

3M and DuraPrep are trademarks of 3M

© 3M 2009 All rights reserved.

Solution:

US Patent 4,584,192

34-8704-4733-0

Principal Display Panel – 6 mL Case Label

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 Applicator Label

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

Solution:

US Patent 4,584,192

34-8704-4731-4

3M and DuraPrep are trademarks of 3M

©3M 2009 All rights reserved.

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: 12/2010 3M Health Care