Povidone-Iodine by Wuxi Medical Instrument Factory POVIDONE-IODINE swab

Povidone-Iodine by

Drug Labeling and Warnings

Povidone-Iodine by is a Otc medication manufactured, distributed, or labeled by Wuxi Medical Instrument Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Item#83791-817-003      NDC#42947-631-03     Qty. 3ea

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

ACTIVE INGREDIENT

Active ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)

PURPOSE

Purpose

Antiseptic

WHEN USING

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

Warnings

For external use only.

DO NOT USE

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.

STOP USE

Discontinue use

If irritation and redness develop. If condition persists for more than 71 hours, consult a doctor.

ASK DOCTOR

Consult a doctor in case of

* deep or puncture wounds * animal bites * serious burns.

INDICATIONS & USAGE

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

ASK DOCTOR

Stop use and consult a doctor

if the condition persists or gets worse.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42947-631
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	POVIDONE-IODINE	0.1 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.0003 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42947-631-03	5.5 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	01/01/2008

Labeler - Wuxi Medical Instrument Factory (421292863)

Registrant - Wuxi Medical Instrument Factory (421292863)

Establishment
Name	Address	ID/FEI	Business Operations
Wuxi Medical Instrument Factory		421292863	manufacture