JIANZE POVIDONE-IODINE - povidone-iodine gel
Changzhou Jianze Sanitary Material Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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JIANZE POVIDONE-IODINE GEL SWABSTICK

ACTIVE INGREDIENT

Povidone-Iodine USP 10%

PURPOSE

Antiseptic

USE:

Antiseptic skin preparation

WARNINGS:

Do not use if allergic to Iodine.

STOP USE AND ASK A DOCTOR IF:

redness, irritation, swelling or pain persists or increases
infection occurs
injuries are deep or puncture wounds or serious burns

KEEP OUT OF REACH OF CHILDREN.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

For External Use Only.

DIRECTIONS

Apply locally as needed.

OTHER INFORMATION

1% titratable iodine
latex free

INACTIVE INGREDIENTS:

Disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, dimethicone, water.

JIANZE POVIDONE-IODINE GEL SWABSTICK 1 COUNT (50666-005-01)

PovidoneIodineGelSwabstick.

JIANZE POVIDONE-IODINE
povidone-iodine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50666-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)	POVIDONE-IODINE	10 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50666-005-01	2.1 g in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333E	06/14/2012

Labeler - Changzhou Jianze Sanitary Material Co., Ltd. (421279569)

Registrant - Changzhou Jianze Sanitary Material Co., Ltd. (421279569)

Name	Address	ID/FEI	Business Operations
Establishment
Changzhou Jianze Sanitary Material Co., Ltd.		421279569	manufacture