POVIDONE-IODINE PREP- povidone-iodine patch

POVIDONE-IODINE PREP by

Drug Labeling and Warnings

POVIDONE-IODINE PREP by is a Otc medication manufactured, distributed, or labeled by Yinjing Medical Technology (Shanghai) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidon-Iodin 10% (w/w)

(equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

• First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

• For external use only

Do not use

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

Stop use and ask a doctor if

• irritation and redness develop 
• condition persists more than 72 hours
• in case of deep or puncture wounds, animal bites or serious burns

Keep out of reach of children.

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

Directions

• Clean the treatment 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

Inactive ingredient

• Purified water

Other information

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE PREP 
povidone-iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44019-100
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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44019-100-00	1 in 1 POUCH	07/07/2017
1		0.45 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	07/07/2017

Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)