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Providone Iodine Prep by Jiangsu Province Jianerkang Medical Dressing Co., Ltd

Medically reviewed on February 3, 2017

Dosage form: solution
Ingredients: POVIDONE-IODINE 10g in 100g
Labeler: Jiangsu Province Jianerkang Medical Dressing Co., Ltd
NDC Code: 34645-5504

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.

Providone Iodine Prep Swabstick

Drug Facts

Active ingredient

Povidone lodine USP, 10% W/V (equivalent to 0.75% titratable iodine)

Purpose

Antiseptic

Use
  • Health-care antiseptic for preparation of the skin prior to surgery 
  • First aid antiseptic to help prevent the risk of skin infection in minor cuts,scrapes,and burns.

Warnings

For external use only.

Do not
  • use in the eyes 
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body 
  • use as a first aid antiseptic longer than 1 week unless directed by a doctor. Discontinue use if irritation and redness develop. Consult a doctor in case of 
  • deep or puncture wounds
  • animal bites 
  • serious burns.

Stop use and consult a doctor

if the condition persists or gets worse.

Keep out of reach of children. 

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

Directions

For preparation of the skin prior to surgery

  • clean the affected area remove swab by stick 
  • apply to the operative site prior to surgery. For use as a first aid antiseptic 
  • clean the affected area 
  • apply a small amount of this product on the area 1-3 times daily 
  • may be covered with a sterile bandage 
  • if bandaged,let dry first.

Other information

store at room temperature: 15°-30°C(59°-86°F)

  • Avoid excessive heat

Inactive ingredients

citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin

Package Labeling:

PROVIDONE IODINE PREP 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-5504
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
WATER 
SODIUM HYDROXIDE 
NONOXYNOL-10 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:34645-5504-010 BOX in 1 CARTON
125 PATCH in 1 BOX
10.045 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/30/2017
Labeler - Jiangsu Province Jianerkang Medical Dressing Co., Ltd (530968767)
Establishment
NameAddressID/FEIOperations
Jiangsu Province Jianerkang Medical Dressing Co., Ltd530968767manufacture(34645-5504)

 
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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