FDA Label for Pvp Iodine Prep Pad Medium And Large

View Indications, Usage & Precautions

Pvp Iodine Prep Pad Medium And Large Product Label

The following document was submitted to the FDA by the labeler of this product Professional Disposables International, Inc.. 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% w/w (equivalent to 1.0% titratable iodine)


Purpose



Antiseptic


Uses



  • A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery.
  • First Aid antiseptic to help prevent the risk of skin infection in minor cut, scrapes and burns.

Warnings



For external use only

Do not use

  • in the eyes, nose or mouth
  • on individuals who are allergic or sensitive to iodine
  • over large areas of the body
  • as a first aid antiseptic longer than one week unless directed by a doctor
  • Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider

    Consult a healthcare provier in case of

    • Deep or puncture wounds
    • animal bites
    • serious burns
    • if you are pregnant
    • Avoid pooling


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



For the preparation of the skin prior to surgery

  • clean the treatment area
  • remove applicator
  • apply to the operative site prior to surgery
  • allow to dry
  • For use as a first aid antiseptic

    • clean the treatment area
    • apply a small amount of this product on the treatment area 1-3 times daily as directed
    • may be covered with a sterile bandage
    • if bandaged, let dry before applying bandage to prevent possible irritation

Other Information



  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients



Purified Water, Sodium Hydroxide


Questions?



Professional Disposables International, Inc.
Orangeburg, NY 10962-1376
USA - 1-800-999-6423
www.pdipdi.com         Made in USA


Principal Display Panel And Labels



Packet 1 swabstick

Box 1 swabstick

Packet 3 swabsticks

Box 3 swabsticks

Packet med

Box med

Packet large

Box large


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