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Povidone Iodine by Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.
NDC Code: 34645-4188

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.

Drug Facts

Active Ingredients

Povidone Iodine, USP 10% (1.0% available Iodine)

Purpose

Antiseptic

Uses

Prepping intact skin and mucous membranes prior to surgery

Warnings

For external use only

Avoid use on persons allergic to iodine

Stop use and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Keep out of reach of children

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

Directions

Patient preoperative prep

use full strength

apply solution to operative site following povidone iodine scrub application

using a circular motion, start at incision site and move outward

remove all soiled underdrapes

do not allow solution to pool


Other information

store at room temperature
avoid excessive heat (above 104oF/40oC)
protect from freezing
latex free

Inactive Ingredients

Citric Acid, Glycerin, Nonoxynol - 10, Purified Water, Sodium hydroxide, hydroxyethylcellulose

Package Label

POVIDONE IODINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4188
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
NONOXYNOL-10 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:34645-4188-688.5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2010
Labeler - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)

 
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.

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Medically reviewed on Dec 30, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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