A4095-18 SINGLE SHOT EPIDURAL 18G TUOHY

Manufacturer
Smiths Medical ASD, Inc. | 3M Company
Effective date
2015-03-20
Label type
MEDICAL DEVICE
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:32:38

Label at a glance#

ProductA4095-18 SINGLE SHOT EPIDURAL 18G TUOHY
Active ingredientIodine povacrylex, Isopropyl alcohol
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Iodine povacrylex (0.7% available iodine)

Isopropyl alcohol, 74% w/w

OTC - PURPOSE SECTION

Antiseptic

patient preoperative skin preparation:

for preparation of the skin prior to surgeryhelps reduce bacteria that potentially can cause skin infection

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 vaporsdo 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 poolremove solution-stained material from prep area

flame figure 1flame figure 1

Do not use

on patients with known allergies to iodine or any other ingredients in this producton open wounds, on mucous membranes, or as a general skin cleanserin 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 filmuse 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.

INSTRUCTIONS FOR USE 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:

use in well-ventilated areado not microwave or heat the solution applicatorapply to clean, completely dry, residue-free, intact skinwhen 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:

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:

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.

pooling figure 1pooling figure 1

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.

cautery figure 1cautery figure 1

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 removedif 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 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 INGREDIENT SECTION

ethyl alcohol, water

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

Surgical Solution 1Surgical Solution 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

A4095-18A4095-18

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 INGREDIENT6E43AWY0832
Isopropyl alcoholACTIVE INGREDIENTND2M4163022
IODINEACTIVE MOIETY9679TC07X42
Isopropyl alcoholACTIVE MOIETYND2M4163022
waterINACTIVE INGREDIENT059QF0KO0R2

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
51688-642651688-6426-2
17518-01117518-011-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Iodine povacrylex6E43AWY083ACTIM
Isopropyl alcoholND2M416302ACTIB
water059QF0KO0RIACT

Source Document#

Source XML

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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021586-001DURAPREPEQ 0.7% IODINE;74% (6ML)SPONGE / TOPICALRLD, RS2006-09-29c2088c7a36db…
2026-10-15 13:18:302026-09N021586-002DURAPREPEQ 0.7% IODINE;74% (26ML)SPONGE / TOPICALRLD, RS2006-09-29c2088c7a36db…
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…

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 (product): 17518-011

Reported adverse events (FAERS/openFDA)#

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