Indications and uses
patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection
3M DuraPrep Surgical
- Manufacturer
- Solventum US OpCo LLC | 3M Company
- Effective date
- 2024-04-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:06:14
Label at a glance#
Product3M DuraPrep Surgical
Active ingredientIodine Povacrylex, Isopropyl Alcohol
Label structure10 sections
Dosage and administration
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...
Contacts and useful links#
Websitewww.3m.com
www.3M.com
www.3M.comLabel contents#
Full prescribing information#
Active ingredients
Iodine povacrylex (0.7% available iodine)
Isopropyl alcohol, 74% w/w
Purpose
Antiseptic
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
OTC - STOP USE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
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.
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.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17518-011-08 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1bb7-111a-e063-dadaa90a10e2 | c951336f-9cb2-40cc-98f3-b5c4d9f5e27d |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17518-011-07 | ML - Milliliter | 17518-011 | 8194a988-b389-48ca-868b-d294b1be4feb | 1 | 2015-10-02 |
| 17518-011-08 | ML - Milliliter | 17518-011 | cebc176f-bd3a-4bea-8b7e-3b62f9db762b | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Iodine povacrylex | ACTIVE INGREDIENT | 6E43AWY083 | 5 | |
| Isopropyl alcohol | ACTIVE INGREDIENT | ND2M416302 | 5 | |
| Iodine | ACTIVE MOIETY | 9679TC07X4 | 5 | |
| Isopropyl alcohol | ACTIVE MOIETY | ND2M416302 | 5 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | 5 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Products#
Every source-derived product name is available through these pages.
- 3M DuraPrep Surgical
- Iodine povacrylex and Isopropyl alcohol
- Iodine Povacrylex
- Iodine
- Isopropyl Alcohol
- Alcohol
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 17518-011 | 17518-011-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Iodine Povacrylex | 6E43AWY083 | ACTIM |
| Isopropyl Alcohol | ND2M416302 | ACTIB |
| Alcohol | 3K9958V90M | IACT |
| Water | 059QF0KO0R | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021586-001 | DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | |
| N021586-002 | DURAPREP | IODINE POVACRYLEX; ISOPROPYL ALCOHOL | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | 74a2ff9319b5… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3M DuraPrep Surgical | IODINE POVACRYLEX AND ISOPROPYL ALCOHOL | Solventum US LLC | 22a10a54-6a04-48b3-9ec4-b26526183daf | 2026-04-23 | Warnings | 17518-011-08 17518-011 17518001108 |
| e2a46554-a189-4a81-b2ad-2297ba11adc0 | c951336f-9cb2-40cc-98f3-b5c4d9f5e27d | 2024-04-01 | Warnings | e2a46554-a189-4a81-b2ad-2297ba11adc0 c951336f-9cb2-40cc-98f3-b5c4d9f5e27d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.