Povidone-iodine swab

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 oC (59 o-86 oF)

Inactive ingredient section

Inactive ingredients

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

Ingredients and appearance - Product information

Povidone-iodine swab- Povidone-iodine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 42947-621
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Povidone-iodine ( UNII: 85H0HZU99M)( Iodine - UNII: 9679TC07X4 ) 0.1 mLin 1 mL

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part333 USA

Labeler - Wuxi Medical Instrument Factory( 421292863)

Establishment

Name ID/FEI Business Operations
Wuxi Medical Instrument Factory 421292863 manufacture()

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

Package label.principal display panel

Pouch Label