POVIDONE IODINE PREP- povidone iodine solution

Povidone Iodine Prep by

Drug Labeling and Warnings

Povidone Iodine Prep by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP 
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NONOXYNOL-9 (UNII: 48Q180SH9T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-132-01	500 in 1 CASE
1		22.18 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/16/2015

Labeler - Sion Biotext Medical Ltd (532775194)

Registrant - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(68786-132)