FDA Label for Povidone Iodine Prep

View Indications, Usage & Precautions

Povidone Iodine Prep Product Label

The following document was submitted to the FDA by the labeler of this product Phoenix Healthcare Solutions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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