POVIDONE-IODINE PREP PAD- povidone-iodine solution

Povidone-Iodine Prep Pad by

Drug Labeling and Warnings

Povidone-Iodine Prep Pad by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 200, Inc., Jianerkang Medical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone-Iodine USP 10% (equivalent to 1% titratable iodine)

Purpose

First Aid Antiseptic

Use

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

Warnings

For external use only. Allergy Alert: Do not apply to persons allergic to Iodine

Do not use

in the eyes or apply over large areas of the body longer than one week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds animal bites serious burns

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

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 15°-30°C (59°-86°F)

Inactive ingredients

(purified) water, glycerol, nonylphenol ethoxylate, citric acid, sodium hydroxide

Package Labeling:

Packet Labeling:

Box Labeling:

Carton Labeling:

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP PAD 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63517-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63517-400-83	10 in 1 CARTON	08/05/2016
1		100 in 1 BOX
1		0.56 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/05/2016

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Province Jianerkang Medical Dressing Co., Ltd		530968767	manufacture(63517-400)