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Povidone Iodine Prep by Sion Biotext Medical Ltd

Medically reviewed on July 16, 2018

Dosage form: solution
Ingredients: POVIDONE-IODINE 1g in 100mL
Labeler: Sion Biotext Medical Ltd
NDC Code: 68786-132

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 ingredient

Povidone Iodine  10% w/v

Purpose

Antiseptic

Uses
  • Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes, and burns
  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that can potentially cause skin infection

Warnings:

For External Use Only.


Do not use
  • In the eyes
  • As a first aid antiseptic for more than 1 week
  • Over large areas of the body


Ask a doctor before use if you have
  • Deep or puncture wounds
  • Animal bites
  • Serious wounds

Stop use and ask a doctor if
  • Condition worsens or persists for more than 72 hours
  • Irritation and redness develops

Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:
  • Tear at notch
  • Use only once

As a first aid antiseptic

  • Clean affected area
  • apply 1 to 3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first.

For preoperative patient skin preparation

  • Clean affected area
  • Apply to operative site prior to surgery using applicator



Other information
  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients:
  • Nonoxynol-9, water

Principal Display Panel

PVP Prep Solution

First Aid Antiseptic

NET WT. 0.75 oz

500 Packets per Case

Made in Israel

NDC 68786-132-01





POVIDONE IODINE PREP 
povidone iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-132
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage Description
1NDC:68786-132-01500 PACKET in 1 CASE
122.18 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/16/2015
Labeler - Sion Biotext Medical Ltd (532775194)
Registrant - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIOperations
Sion Biotext Medical Ltd532775194manufacture(68786-132)

 
Sion Biotext Medical Ltd

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Further information

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

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