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Povidone-Iodine by Wuxi Medical Instrument Factory

Medically reviewed on Mar 1, 2018

Dosage form: swab
Ingredients: POVIDONE-IODINE 0.1mL in 1mL
Labeler: Wuxi Medical Instrument Factory
NDC Code: 42947-631

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

Povidone Iodine USP, 10% w/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 * 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.


Discontinue use

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


Consult a doctor in case of

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


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


Stop use and consult a doctor

if the condition persists or gets worse.


Keep out of reach of children.

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


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


Other information

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

Inactive ingredients

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

POVIDONE-IODINE 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42947-631
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) POVIDONE-IODINE0.1 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE0.0003 mL  in 1 mL
Packaging
#Item CodePackage Description
1NDC:42947-631-035.5 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33301/01/2008
Labeler - Wuxi Medical Instrument Factory (421292863)
Registrant - Wuxi Medical Instrument Factory (421292863)
Establishment
NameAddressID/FEIOperations
Wuxi Medical Instrument Factory421292863manufacture

 
Wuxi Medical Instrument Factory

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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