POVIDONE-IODINE PREP PAD MEDIUM STERILE- povidone-iodine pad cloth

Povidone-Iodine Prep Pad Medium Sterile by

Drug Labeling and Warnings

Povidone-Iodine Prep Pad Medium Sterile by is a Otc medication manufactured, distributed, or labeled by Zhejiang Xingheng Medical Supplies Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-lodine 10% w/w (equivalent to iodine 1%)

PURPOSE

Antiseptic

WARNINGS

For external use only.

WHEN USING

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

DO NOT USE

Do not use:

• in the eyes.
• apply over large areas of the body.
• 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 1week.

ASK DOCTOR

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 Poison Control Center right away.

INACTIVE INGREDIENT

Sodium Bicarbonate, Polysorbate 20, Polyethylene Glycol 400, Potassium Iodate, Water

DOSAGE & ADMINISTRATION

Apply topically as needed to cleanse intendend area；

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.

INDICATIONS & USAGE

Use for preparation of skin prior to injection，apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be 1min.Please clean before disinfection.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP PAD MEDIUM STERILE 
povidone-iodine pad cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81636-006
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	0.01 g  in 100 g
POTASSIUM IODATE (UNII: I139E44NHL)	0.01 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.01 g  in 100 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO)	0.01 g  in 100 g
WATER (UNII: 059QF0KO0R)	89.96 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81636-006-01	100 in 1 CARTON	08/16/2022
1		100 in 1 BOX
1		5.5 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	08/16/2022

Labeler - Zhejiang Xingheng Medical Supplies Co., Ltd. (554554581)

Registrant - Zhejiang Xingheng Medical Supplies Co., Ltd. (554554581)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Xingheng Medical Supplies Co., Ltd.		554554581	manufacture(81636-006)