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

Medically reviewed on December 30, 2017

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.
NDC Code: 34645-4059

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 10%

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 using this product 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

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

Glycerin, Nonoxynol - 10, Purified Water

Package Label

POVIDONE IODINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4059
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
NONOXYNOL-10 
WATER 
Packaging
#Item CodePackage Description
1NDC:34645-4059-659 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)
Establishment
NameAddressID/FEIOperations
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.530968767manufacture(34645-4059)

 
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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