3M DuraPrep Surgical - Solventum US LLC | 3M Company

Manufacturer
Solventum US LLC | 3M Company
Effective date
2026-04-23
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:55:00

Label at a glance#

Product3M DuraPrep Surgical
Active ingredientIodine Povacrylex, Isopropyl Alcohol
Label structure10 sections

Indications and uses

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

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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Iodine povacrylex (0.7% available iodine)

Isopropyl alcohol, 74% w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Antiseptic

Uses

INDICATIONS & USAGE SECTION

patient preoperative skin preparation:

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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)

DOSAGE & ADMINISTRATION SECTION

  • 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:

SPL UNCLASSIFIED SECTION

  • 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:

SPL UNCLASSIFIED SECTION

  • 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.

When Applying Solution:

SPL UNCLASSIFIED SECTION

  • 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.

After Applying Solution:

SPL UNCLASSIFIED SECTION

  • 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:

SPL UNCLASSIFIED SECTION

  • 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:

SPL UNCLASSIFIED SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

ethyl alcohol, water

Questions?

OTC - QUESTIONS SECTION

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

Principle Display Panel – 6 mL Applicator Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 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 – 6 mL Applicator Label
Principle Display Panel – 6 mL Applicator Label

Principal Display Panel – 6 mL Insert Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Latex-Free

Not Made With Natural Latex

Do Not Reuse

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

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 – 6 mL Insert Label
Principal Display Panel – 6 mL Insert Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1090522DuraPrep 0.7 % / 74 % Topical SolutionPSN13
692866iodine povacrylex 0.7 % / isopropyl alcohol 74 % Topical SolutionPSN13
1090522iodine povacrylex 7 MG/ML / isopropyl alcohol 0.74 ML/ML Topical Solution [DuraPrep]SBD13
692866iodine povacrylex 7 MG/ML / isopropyl alcohol 0.74 ML/ML Topical SolutionSCD13
1090522DuraPrep (iodine 0.7 % / isopropyl alcohol 74 % ) Topical SolutionSY13
692866iodine povacrylex 0.7 % / isopropyl alcohol 74 % Topical SolutionSY13

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)00317518011078GTIN-14: 00317518011078
GTIN-12: 317518011078
UPC-A: 317518011078
EAN-13: 0317518011078
GTIN storage (14 digits): 00317518011078
3mx07-0010-01.jpg, 3mx07-0010-02.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17518-011-072024-01-30C16284748780-11030e365-3819-111a-e063-dadaa90a10e222a10a54-6a04-48b3-9ec4-b26526183daf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17518-011-073M DuraPrep Surgical6 mL in 1 APPLICATORSOLUTION613
17518-011-073M DuraPrep Surgical1 in 1 CASESOLUTION113
17518-011-083M DuraPrep Surgical26 mL in 1 APPLICATORSOLUTION2613
17518-011-083M DuraPrep Surgical1 in 1 CASESOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17518-011-07ML - Milliliter17518-0118194a988-b389-48ca-868b-d294b1be4feb12015-10-02
17518-011-08ML - Milliliter17518-011cebc176f-bd3a-4bea-8b7e-3b62f9db762b12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Iodine povacrylexACTIVE INGREDIENT6E43AWY0831
Isopropyl alcoholACTIVE INGREDIENTND2M4163021
IodineACTIVE MOIETY9679TC07X41
Isopropyl alcoholACTIVE MOIETYND2M4163021
alcoholINACTIVE INGREDIENT3K9958V90M1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17518-01117518-011-07, 17518-011-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML · Source PDF

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.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021586-001DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29
N021586-002DURAPREPIODINE POVACRYLEX; ISOPROPYL ALCOHOLEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-2984e616aacf4f…
2026-08-18 06:07:402026-07N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-2974a2ff9319b5…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
ndc (package): 17518-011-07
ndc (package): 17518-011-08
ndc (product): 17518-011
ndc11 (package): 17518001108
ndc11 (package): 17518001107
spl id: 6f88810b-2554-4c4f-8604-25fe4b695a2d
spl set id: 22a10a54-6a04-48b3-9ec4-b26526183daf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.