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Povidone Iodine Topical Solution Paint

Medically reviewed on April 2, 2018

Dosage form: liquid
Ingredients: POVIDONE-IODINE 100mg in 1mL
Labeler: Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
NDC Code: 34645-1040

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.

Povidone Iodine Topical Solution Paint

Drug Facts

Active Ingredient

Povidone-Iodine, USP 10%

(1.0% available iodine)

Purpose

patient preoperative prep

Use

prepping intact skin and mucous membranes prior to sugery

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 a 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 no allow solution to pool

Other information
  • store at room temperature
  • avoid excessive heat (above 104 degrees F/40 degrees C)
  • protect from freezing
  • latex free

Inactive Ingredients

Purified Water, nonylphenol ethoxylate, glycerol

Package Labeling

POVIDONE IODINE TOPICAL SOLUTION PAINT 
povidone iodine 10% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-1040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
NONOXYNOL-9 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:34645-1040-13785 mL in 1 BOTTLE
2NDC:34645-1040-259 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/31/2015
Labeler - Jiangsu Province Jianerkang Medical Dressing Co., Ltd. (530968767)
Establishment
NameAddressID/FEIOperations
Jiangsu Province Jianerkang Medical Dressing Co., Ltd.530968767manufacture(34645-1040)

 
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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