Povidone Iodine by Jianerkang Medical Co., Ltd POVIDONE IODINE swab

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Jianerkang Medical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Povidone lodine 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. Consult a doctor in case of 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 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: 15°－30°C(59°-86°F)

Inactive Ingredients

citric acid, purified water, sodium hydroxide, nonylphenol ethoxylate, glycerin

Package Label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-1029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-1029-1	3 in 1 POUCH	09/10/2015
1		45 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/10/2015

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

Registrant - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.		530968767	manufacture(34645-1029)