3m Duraprep Surgical Solution
FDA Label NDC 17518-011

Drug Facts

Iodine povacrylex (0.7% available iodine)

Isopropyl alcohol, 74% w/w

Antiseptic

Antiseptic

patient preoperative skin preparation:

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

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 (3mx07 0004 01)

• 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

• 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.

• 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.

• 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.

• 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.

• 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 (3mx07 0004 02)

• 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.

• 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 (3mx07 0004 03)

• 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

• store between 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• solution is not water soluble and may stain. Therefore, avoid contact with reusable items (basins, instruments).

ethyl alcohol, water

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

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 (3mx07 0004 04)

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 (3mx07 0004 06)

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 (3mx07 0004 05)

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 (3mx07 0004 07)