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

Dosage form: solution
Ingredients: POVIDONE-IODINE 7.5mg in 1mL
Labeler: Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.
NDC Code: 34645-4009

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 7.5% (0.75% available Iodine)

Purpose

Antiseptic

Uses

For preparation of 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 saturated sponge to operative site

scrub in circular motion for 5 minutes starting at incision site and move outward

blot with sterile towel

follow with application of topical solution


Other information

store at room temperature
avoid excessive heat (above104oF/40oC)
protect from freezing
latex free

Inactive Ingredients

alkyl polyglucoside, citric acid, nonoxynol - 10, purified water, sodium hydroxide

Package label

POVIDONE IODINE 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
NONOXYNOL-10 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:34645-4009-6109 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(34645-4009)

 
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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