JIANZE POVIDONE-IODINE- povidone-iodine gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)

Available from:

Changzhou Jianze Sanitary Material Co., Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

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
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)
JIANZE POVIDONE-IODINE
povidone-iodine gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 6 6 6 -0 0 5
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (POVIDONE-IODINE - UNII:8
5H0 HZU9 9 M)
POVIDONE-IODINE
10 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
SO DIUM PHO SPHATE, DIBASIC, ANHYDRO US (UNII: 22ADO53M6 F)
GLYCERIN (UNII: PDC6 A3C0 OX)
NO NO XYNO L-10 (UNII: K7O76 8 8 7AP)
DIMETHICO NE (UNII: 9 2RU3N3Y1O)
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:50 6 6 6 -0 0 5-0 1
2.1 g in 1 POUCH
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt333E
0 6 /14/20 12
LABELER -
Changzhou Jianze Sanitary Material Co., Ltd.