POVIDONE IODINE PREP- povidone-iodine swab

Povidone Iodine Prep by

Drug Labeling and Warnings

Povidone Iodine Prep 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 Iodine USP, 10% W/V (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

• 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 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 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: 15°—30°C(59°-86°F)

• Avoid excessive heat

Inactive ingredients

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

34645-5506-0

34645-5506-1

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-5506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-5506-0	500 in 1 CARTON	08/01/2019
1		1 in 1 POUCH
1		2.5 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 34645-5506-1	250 in 1 CARTON	08/01/2019
2		3 in 1 POUCH
2		13.5 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/01/2019

Labeler - Jianerkang Medical Co., Ltd (530968767)

Establishment
Name	Address	ID/FEI	Business Operations
Jianerkang Medical Co., Ltd		530968767	manufacture(34645-5506) , label(34645-5506)