Label at a glance#

ProductPovidone-Iodine

Active ingredientPOVIDONE-IODINE

Label structure15 sections

Storage and handling

Other information Store at room temperature: 15 o - 30 o C (59 o -86 o F)

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Item# 83791-817-001 NDC# 42947-621-01 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

Manufactured by:

Wuxi Medical Instrument Factory

No.86 East Street, Zhangjing, Wuxi, Jiangsu 214194 China

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: 15^o - 30^o C (59^o-86^o F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aitric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pouch Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42947-621-01	2025-07-15	C162847	48780-1	9d75b9d0-a34e-f424-e053-dadaa90a57ce	Drug Facts
42947-621-01	2020-01-31	C162847	48780-1	9d75b9d0-a34e-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42947-621	POVIDONE-IODINE SWAB [WUXI MEDICAL INSTRUMENT FACTORY]	3	Legacy NDC	20100331_27ebc398-251c-46a6-bea7-8bc9adb3e2b8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
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.

DailyMed product names page 1 of 1 · 2 matching rows.

Povidone-Iodine
IODINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42947-621	42947-621-01

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
POVIDONE-IODINE	85H0HZU99M	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
396fbf3e-50d1-78ec-e063-6394a90a7ab5			27ebc398-251c-46a6-bea7-8bc9adb3e2b8	2025-07-08	Warnings	Exact identifier spl set id: 27ebc398-251c-46a6-bea7-8bc9adb3e2b8

Reported adverse events (FAERS/openFDA)#

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