POVIDONE-IODINE PREP PAD- povidone-iodine swab

Povidone-Iodine Prep Pad by

Drug Labeling and Warnings

Povidone-Iodine Prep Pad 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# 83791-817-030      NDC# 42947-611-10     Qty. 1ea

Povidone-Iodine Prep Pad

Antiseptic/Germicide, Medium*For Single Use Only

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

First Aid

Antiseptic

WHEN USING

Use

First aid to help prevent infection in minor cuts, scrapes, and burns

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not * use in the eyes * apply over large areas of the body

* use on individuals who are allergic or sensitive to iodine

STOP USE

Stop use and consult a doctor

if the condition persists or gets worse

for use longer than 1 week

ASK DOCTOR

Ask a doctor

in case of deep or puncture wounds, animal bites, serious burns.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

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

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP PAD 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42947-611
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42947-611-10	0.5 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	01/01/2009

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