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Povidone Iodine Prep by PHOENIX HEALTHCARE SOLUTIONS, LLC

Medically reviewed on October 25, 2017

Dosage form: swab
Ingredients: POVIDONE-IODINE 1g in 100mL
Labeler: PHOENIX HEALTHCARE SOLUTIONS, LLC
NDC Code: 60913-999

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 USP 10% v/v

Purpose

Antiseptic

Uses
  • 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
  • apply a small amount of this product on the area

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: 59o - 86oF (15o - 30oC)


Inactive ingredients:

citric acid, glycerin, Makon 8, purified water, sodium hydroxide


Principal Display Panel

Phoenix Healthcare Solutions LLC

An Innovative Medical Manufacturer

NDC 60913-999-02

200 Individual Pads

Povidone Iodine Prep Pads

Medium

For Individual, Professional and Hospital Use

Saturated with 10% Povidone Iodine for external use only

Latex Free

PIN DOT WOVEN



POVIDONE IODINE PREP  
povidone iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60913-999
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:60913-999-02200 PACKET in 1 CARTON
11 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/26/2015
Labeler - PHOENIX HEALTHCARE SOLUTIONS, LLC (079146847)

 
PHOENIX HEALTHCARE SOLUTIONS, LLC

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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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