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 Jianerkang Medical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone lodine USP,10% w/v (equivalent to 1% titratable iodine)

First Aid Antiseptic

Use

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

Warnings

For external use only.

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 and consult a doctor

• if the condition persists or gets worse 
• for use longer than 1 week.

Ask a doctor

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

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 product on the area 1-3 times daily and discard 
• May be covered with a sterile bandage when dry

Other information

• Avoid excessive heat 
• store at room temperature: 15°－30°C(59°-86°F)

Inactive ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP PAD 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-5500
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-5500-0	1 in 1 CARTON	01/30/2017	01/30/2017
1		100 in 1 BOX
1		0.043 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 34645-5500-1	1 in 1 CARTON	01/30/2017
2		100 in 1 BOX
2		0.043 g in 1 PATCH; 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	01/30/2017

Labeler - Jiangsu Province Jianerkang Medical Dressing Co., Ltd (530968767)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Province Jianerkang Medical Dressing Co., Ltd		530968767	manufacture(34645-5500)