Povidone Iodine Prep Pad

Povidone Iodine Prep Pad

Drug Labeling and Warnings

Drug Details

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POVIDONE IODINE - povidone-iodine swab 
Sion Biotext Medical Ltd

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.

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Povidone Iodine Prep Pad

Active Ingredient

Povidone Iodine 10%

Purpose

Antiseptic

Uses

  • Antiseptic cleanser to help prevent 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 longer than 1 week
  • Over large areas of the body

Ask a doctor before use if you have

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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 right away.

Directions

  • Tear at notch
  • Remove applicator
  • Use only once

As a first aid antispetic

  • Clean affected area
  • apply 1-3 times daily
  • May be covered with a sterile bandage
  • If bandaged, let dry first.
For preoperative patient skin preparation

  • Clean 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

50

Packets

Povidone-Iodine

Swabsticks

Antispetic/Germicide

For External Use Only

Sion Biotext

Medical Ltd.Untitledd.jpg

POVIDONE IODINE 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68786-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.10 g
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68786-130-0150 in 1 BOX
11 in 1 PACKET
2NDC: 68786-130-0225 in 1 BOX
23 in 1 PACKET
3NDC: 68786-130-0350 in 1 BOX
31 in 1 PACKET
4NDC: 68786-130-0450 in 1 BOX
41 in 1 PACKET
5NDC: 68786-130-0525 in 1 BOX
53 in 1 PACKET
6NDC: 68786-130-0650 in 1 BOX
61 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/17/2013
Labeler - Sion Biotext Medical Ltd (532775194)

Revised: 4/2013
 
Sion Biotext Medical Ltd


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