Pvp Iodine Prep Pad Swab
FDA Label NDC 10819-3883

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Professional Disposables International, Inc. for the product Pvp Iodine Prep Pad (NDC 10819-3883). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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