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  5. Label Information: Povidone Iodine Prep Swabstick

FDA Label for Povidone Iodine Prep Swabstick

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS:
    5. DO NOT
    6. CONSULT A DOCTOR IN CASE OF
    7. STOP USE AND CONSULT A DOCTOR
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS:
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS:
    12. PRINCIPAL DISPLAY PANEL

Povidone Iodine Prep Swabstick 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



NDC 60913-051-01

Phoenix Healthcare Solutions LLC

"An Innovative Medical Manufacturer"

Povidone Iodine Swabsticks

10% Povidone Iodine, USP

For Professional and Hospital Use

Antispetic/ Germicide

50 Pouches Per Box

1 Swabstick Per Pouch

Label - 01

Label - 01

NDC 60913-051-03

Phoenix Healthcare Solutions LLC

"An Innovative Medical Manufacturer"

Povidone Iodine Swabsticks

10% Povidone Iodine, USP

For Professional and Hospital Use

Antispetic/ Germicide

25  Pouches Per Box

3  Swabsticks Per Pouch


* Please review the disclaimer below.