Storage and handling
Other information Store at room temperature: 15 o - 30 o C (59 o -86 o F)
Povidone-Iodine
- Manufacturer
- Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. | Jiangsu Province JianErKang Medical Dressing Co. , Ltd.
- Effective date
- 2010-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:24:06
Label at a glance#
ProductPovidone-Iodine
Active ingredientPOVIDONE-IODINE
Label structure15 sections
Label contents#
Full prescribing information#
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cat.40000-040 NDC 34645-4000-2 Qty. 1ea
Povidone-Iodine Swab Stick
Antiseptic/Germicide * For Single Use Only * Avoid storing at excessive heat
Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine
For External Use Only
Distributed by:
Cardinal Health
Dublin, OH 43017 USA
Made in China
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Povidone Iodine USP, 10% w/v
(equivalent to 1% titratable iodine)
OTC - PURPOSE SECTION
Purpose
Antiseptic
OTC - WHEN USING SECTION
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 SECTION
Warnings
For external use only.
OTC - DO NOT USE SECTION
Do not * use in the eyes * use on individuals who are allergic or sensitive to iodine
* apply over large areas of the body * use as a first aid antiseptic longer than 1 week unless directed by a doctor.
OTC - STOP USE SECTION
Discontinue use
If irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.
OTC - ASK DOCTOR SECTION
Consult a doctor in case of
* deep or puncture wounds * animal bites * serious burns.
INDICATIONS & USAGE SECTION
Directions
Clean the affected area
Apply product on the area 1-3 times daily and discard
May be covered with a sterile bandage when dry
OTC - ASK DOCTOR 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.
INDICATIONS & USAGE SECTION
Directions
For preparation of the skin prior to surgery
* clean the affected area
* remove swab by stick
* apply to the operative site prior to surgery
For use as a first aid antiseptic
* clean the affected area
* apply a small amount of this product on the area 1-3 times daily
* may be covered with a sterile bandage
* if bandaged, let dry first
STORAGE AND HANDLING SECTION
Other information
Store at room temperature: 15o - 30o C (59o-86o F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
aitric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Image of Pouch Label
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 3 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 3 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 3 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 3 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | 3 |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 34645-4000-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2e30-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 34645-4000-2 | Povidone-Iodine | 1.7 mL in 1 POUCH | SWAB | 1.7 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 34645-4000 | POVIDONE-IODINE SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. ,LTD.] | 3 | Legacy NDC, 1 package rows | 20100331_cb5c846e-0234-4ffa-8c12-40ea78ccaf1e.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| POVIDONE-IODINE | ACTIVE INGREDIENT | 85H0HZU99M | 3 | |
| IODINE | ACTIVE MOIETY | 9679TC07X4 | 3 |
Products#
Every source-derived product name is available through these pages.
- Povidone-Iodine
- IODINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 34645-4000 | 34645-4000-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE-IODINE | 85H0HZU99M | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 5a2f0be9-4622-48a3-be3c-30afaffb3845 | cb5c846e-0234-4ffa-8c12-40ea78ccaf1e | 2010-01-01 | Warnings | 5a2f0be9-4622-48a3-be3c-30afaffb3845 cb5c846e-0234-4ffa-8c12-40ea78ccaf1e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.