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#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
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
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.
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 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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Label Display Panel
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 | 2 | |
| Isopropyl alcohol | ACTIVE INGREDIENT | ND2M416302 | 2 | |
| IODINE | ACTIVE MOIETY | 9679TC07X4 | 2 | |
| Isopropyl alcohol | ACTIVE MOIETY | ND2M416302 | 2 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- A4095-18 SINGLE SHOT EPIDURAL 18G TUOHY
- 3M DuraPrep Surgical
- Iodine povacrylex and Isopropyl alcohol
- Iodine povacrylex
- IODINE
- Isopropyl alcohol
- water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51688-6426 | 51688-6426-2 |
| 17518-011 | 17518-011-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Iodine povacrylex | 6E43AWY083 | ACTIM |
| Isopropyl alcohol | ND2M416302 | ACTIB |
| water | 059QF0KO0R | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N021586-001 | DURAPREP | EQ 0.7% IODINE;74% (6ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N021586-002 | DURAPREP | EQ 0.7% IODINE;74% (26ML) | SPONGE / TOPICAL | RLD, RS | 2006-09-29 | c2088c7a36db… | |
| 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… |
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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.




