Indications and uses
health care antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
Povidone-Iodine
- Manufacturer
- Mazza Healthcare, LLC
- Effective date
- 2024-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:38:54
Label at a glance#
ProductPovidone-Iodine
Active ingredientPovidone-Iodine
Label structure11 sections
Dosage and administration
clean the affected area for preparation of the skin prior to surgery, apply product to the operative site for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Povidone-Iodine, USP, 10% v/v
(equivalent to 1% titratable iodine)
Purpose
Antiseptic
Uses
- health care antiseptic for preparation of the skin prior to surgery
- first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
Warnings
For external use only
Do not use
- in the eyes
- on individuals who are allergic or sensitive to iodine
- over large areas of the body
- as first aid antiseptic longer than 1 week unless directed by doctor
Discontinue use if irritation and redness develop.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
OTC - STOP USE SECTION
Stop use and consult a doctor if the condition persists or gets worse.
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
- clean the affected area
- for preparation of the skin prior to surgery, apply product to the operative site
- for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
Other information
Store at room temperature 59-86ºF (15-30ºC).
Inactive ingredients
citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide
Mazza Healthcare, LLC
1-877-629-9242
Principal Display Panel - 500 Pouch Carton Label
MH
Mazza Healthcare
MODEL NO.: 02-053-00
DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE
QUANTITY: 1 CASE (500 POUCHES X 3 EACH)
LOT NO.:
MANUFACTURE DATE:
EXPIRY DATE:
MANUFACTURED FOR:
Mazza Healthcare, LLC
Bannockburn, IL 60015 • USA
MADE IN CHINA
NDC 81280-003-03
Principal Display Panel - 3 Applicators Pouch Label
MH
Mazza Healthcare
Povidone-Iodine Swabsticks
NDC 81280-003-03
Antiseptic • Germicide • 4” Saturated
Non-Sterile • Single Use Only
3/pouch
Reorder Number 02-053-00
Principal Display Panel - 500 Pouch Carton Label
MH
Mazza Healthcare
MODEL NO.: 02-051-00
DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE
QUANTITY: 1 CASE (500 POUCHES X 1 EACH)
LOT NO.:
MANUFACTURE DATE:
EXPIRY DATE:
MANUFACTURED FOR:
Mazza Healthcare, LLC
Bannockburn, IL 60015 • USA
MADE IN CHINA
NDC 81280-003-01
Principal Display Panel - 1 Applicator Pouch Label
MH
Mazza Healthcare
Povidone-Iodine Swabstick
NDC 81280-003-01
Antiseptic • Germicide • 4” Saturated
Non-Sterile • Single Use Only
1/pouch
Reorder Number 02-051-00
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81280-003-01 | Povidone-Iodine | 1 in 1 POUCH | SWAB | 1 | 2 | |
| 81280-003-01 | Povidone-Iodine | 500 in 1 CARTON | SWAB | 500 | 2 | |
| 81280-003-03 | Povidone-Iodine | 500 in 1 CARTON | SWAB | 500 | 2 | |
| 81280-003-03 | Povidone-Iodine | 3 in 1 POUCH | SWAB | 3 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Povidone-Iodine
- Iodine
- Citric Acid Monohydrate
- Glycerin
- Nonoxynol-10
- Water
- Sodium Hydroxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81280-003 | 81280-003-01, 81280-003-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Povidone-Iodine | 85H0HZU99M | ACTIM |
| Citric Acid Monohydrate | 2968PHW8QP | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Nonoxynol-10 | K7O76887AP | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Hydroxide | 55X04QC32I | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Povidone-Iodine | POVIDONE-IODINE | Mazza Healthcare, LLC | 31df570a-35ae-41a2-b04a-fce65e9d596d | 2024-11-21 | Warnings | 81280-003-01 81280-003-03 81280-003 81280000303 81280000301 58d9f789-b981-422e-8042-16dfeea07447 31df570a-35ae-41a2-b04a-fce65e9d596d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.