3M DURAPREP SURGICAL- iodine povacrylex and isopropyl alcohol solution 
Solventum US OpCo LLC

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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:

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)

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

Inactive ingredients

ethyl alcohol, water

Questions?

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

Principle 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

Non-Sterile Solution

Applicator is sterile if package is intact

REF 8630 0.9 fl oz • 26 mL

External Use Only

Professional Use Only

Read Drug Facts Information before use.

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

2510 Conway Ave., St. Paul, MN 55144

1-800-228-3957 © 2017, 3M. All rights reserved.

3M and DuraPrep are trademarks of 3M.

Principle Display Panel – 26 mL Applicator Label

Principal Display Panel – 26 mL Insert Label

3M

STERILE EO

NDC 17518-011-08

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 large prep areas below the neck

Do Not Reuse

Latex-Free

Not Made With Natural Rubber Latex

Single Use

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. by

3M Health Care

2510 Conway Ave.

St. Paul, MN 55144

1-800-228-3957

© 2021, 3M. All rights reserved.

3M and DuraPrep are trademarks of 3M.

Principal Display Panel – 26 mL Insert Label
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:17518-011-081 in 1 CASE09/29/2006
126 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 - Solventum US OpCo LLC (006173082)
Establishment
NameAddressID/FEIBusiness Operations
3M Company 054950670ANALYSIS(17518-011) , PACK(17518-011)
Establishment
NameAddressID/FEIBusiness Operations
3M Company078671244MANUFACTURE(17518-011)
Establishment
NameAddressID/FEIBusiness Operations
3M Company830016148ANALYSIS(17518-011)

Revised: 4/2024
Document Id: e2a46554-a189-4a81-b2ad-2297ba11adc0
Set id: c951336f-9cb2-40cc-98f3-b5c4d9f5e27d
Version: 12
Effective Time: 20240401
 
Solventum US OpCo LLC