Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Use in a well ventilated area Maximal treatment area for one applicator is approximately 4 in. x 5 in. (129 cm²). Do not use 3-ml applicator for head and neck surgery Remove applicator from package; do not touch sponge hold the applicator with the sponge down. Open the switch only once to act...
Store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C(104°F)
Povidone-Iodine 8.3% w/w
Isopropyl alcohol 72.5% w/w
Antiseptic
for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
For external use only.
Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY:
Do not use 3-ml applicator for head and neck surgery
Solution contains alcohol and gives off flammable vapors
Avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable
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)
Do not allow solution to pool
Remove wet materials from prep area
On patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
For lumbar puncture or in contact with the meninges
On open skin wounds or as a general skin cleanser
keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.
if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
If swallowed, get medical help or contact a Poison Control Center right away.
Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Use in a well ventilated area
Maximal treatment area for one applicator is approximately 4 in. x 5 in. (129 cm²).
Do not use 3-ml applicator for head and neck surgery
Remove applicator from package; do not touch sponge hold the applicator with the sponge down. Open the switch only once to activate the ampules and release the antiseptic.
Wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
Completely wet the treatment area with antiseptic
Dry surgical sites(e.g. abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds
Moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes
Do not allow solution to pool; tuck prep towels to absorb solution, and then remove
Allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away.
Discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.
Store between 15-30°C (59-86°F) avoid freezing and excessive heat above 40°C(104°F)
Purified water
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84128-009-03 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 1 in 1 BAG | SWAB | 1 | 1 | |
| 84128-009-03 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 20 in 1 BOX | SWAB | 20 | 1 | |
| 84128-009-06 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 1 in 1 BAG | SWAB | 1 | 1 | |
| 84128-009-06 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 20 in 1 BOX | SWAB | 20 | 1 | |
| 84128-009-10 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 10 in 1 BOX | SWAB | 10 | 1 | |
| 84128-009-10 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 1 in 1 BAG | SWAB | 1 | 1 | |
| 84128-009-26 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 1 in 1 BAG | SWAB | 1 | 1 | |
| 84128-009-26 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 10 in 1 BOX | SWAB | 10 | 1 | |
| 84128-009-30 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 1 in 1 BAG | SWAB | 1 | 1 | |
| 84128-009-30 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 10 in 1 BOX | SWAB | 10 | 1 | |
| 84128-009-35 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 1 in 1 BAG | SWAB | 1 | 1 | |
| 84128-009-35 | Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | 10 in 1 BOX | SWAB | 10 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 84128-009 | 84128-009-03, 84128-009-06, 84128-009-10, 84128-009-26, 84128-009-30, 84128-009-35 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| POVIDONE-IODINE | 85H0HZU99M | ACTIM |
| ISOPROPYL ALCOHOL | ND2M416302 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA) | POVIDONE-IODINE, ISOPROPYL ALCOHOL | XINXIANG XINDA TECHNOLOGY CO.,LTD | 529b8ad6-081e-0ef8-e063-6294a90a67df | 2026-05-24 | Warnings | 84128-009-30 84128-009-03 84128-009-10 84128-009-26 84128-009-35 84128-009-06 84128-009 84128000906 84128000910 84128000926 84128000935 84128000903 84128000930 529b8aca-4b37-a642-e063-6394a90a2cb0 529b8ad6-081e-0ef8-e063-6294a90a67df |
Adverse event summaries are temporarily unavailable. Other product information remains available.