JIANZE POVIDONE IODINE SCRUB - povidone-iodine liquid 
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 SCRUB SWABSTICK

JIANZE POVIDONE IODINE SCRUB SWABSTICK


ACTIVE INGREDIENT

Povidone Iodine USP, 10% W/V (equivalent to 1% tiratable iodine)

PURPOSE

Antiseptic

USE:

WARNINGS:

For External Use Only

Do not
Discontinue use if irritation and redness develop

Consult a doctor in case of

STOP USE AND CONSULT A DOCTOR

it the condition persists or gets worse.

KEEP OUT OF REACH OF CHILDREN.

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

DIRECTIONS

For preparation of the skin prior to surgery
For use as a first aid antiseptic

OTHER INFORMATION

Store at room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

INACTIVE INGREDIENTS:

Citric Acid, Purified Water, Sodium Hydroxide, Nonoxynol-10, Glycerin

JIANZE POVIDONE IODINE SCRUB SWABSTICK 25 COUNT of 3 swabsticks (50666-006-01)


PovidoneIodineScrubSwabstick3

PovidoneIodineScrubSwabstick3Outer

JIANZE POVIDONE IODINE SCRUB 
povidone-iodine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50666-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
NONOXYNOL-10 (UNII: K7O76887AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50666-006-0125 in 1 BOX
14.5 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E06/14/2012
Labeler - Changzhou Jianze Sanitary Material Co., Ltd. (421279569)
Registrant - Changzhou Jianze Sanitary Material Co., Ltd. (421279569)
Establishment
NameAddressID/FEIBusiness Operations
Changzhou Jianze Sanitary Material Co., Ltd.421279569manufacture

Revised: 6/2012
Document Id: c6df728b-a711-4e1f-acc8-6e188c1368de
Set id: 4f669107-3869-454f-a82a-61a384422fcb
Version: 2
Effective Time: 20120620
 
Changzhou Jianze Sanitary Material Co., Ltd.