ZONSEN POVIDONE-IODINE PREP PAD- povidone-iodine swab

Zonsen Povidone-Iodine Prep Pad by

Drug Labeling and Warnings

Zonsen Povidone-Iodine Prep Pad by is a Otc medication manufactured, distributed, or labeled by Wuhan Zonsen Medical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Povidone-Iodine 10% w/w (1% available iodine)

Purpose

Antiseptic

Use

• Healthcare antiseptic for preparation of the skin prior to surgery.
• First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Warnings

• For external use only.

Do not use

• in the eyes.
• longer than 1 week unless directed by a doctor.
• on individuals who are allergic or sensitive to iodine.
• or apply over large areas of the body.

Stop use and ask a doctor if

• If irritation and redness develop.
• condition persist for more than 72 hours.
• In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the affected area.
• For preparation of the skin prior to surgery: apply product to the operative site prior to surgery 
• For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Inactive Ingredients:

Sodium hydroxide, water

Other information

• Protect from freezing
• Avoid excessive heat.

Package Labeling:

INGREDIENTS AND APPEARANCE

ZONSEN POVIDONE-IODINE PREP PAD 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72932-003
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 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72932-003-00	1 in 1 POUCH	04/01/2019
1		0.45 mL in 1 PACKET; 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	04/01/2019

Labeler - Wuhan Zonsen Medical Products Co., Ltd. (554474517)

Establishment
Name	Address	ID/FEI	Business Operations
Wuhan Zonsen Medical Products Co., Ltd.		554474517	manufacture(72932-003)