Medichoice Pvp Swabsticks Swab
FDA Label NDC 39892-0804

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O&m Halyard, Inc. for the product Medichoice Pvp Swabsticks (NDC 39892-0804). 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, use, warnings, do not use, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Povidone Iodine 10% (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Use

  • Healthcare topical antiseptic for preparation of the skin prior to surgery
  • Topical first aid antiseptic to help reduce the risk of skin infection in minor cuts, scrapes and burns.

Warnings

For external use only.

Do Not Use

  • in the eyes
  • 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.

Stop Use And Ask A Doctor

  • if irritation and redness develop
  • if condition persists or gets worse
  • infection occurs

    • Consult a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns.

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 treatment area
  • Remove swab by the stick
  • Apply to the operative site prior to surgery.

    • For use as a first aid antiseptic

    • Clean the treatment area
    • Apply a small amount on the treatment area 1-3 times daily
    • May be covered with a sterile bandage
    • Let dry before covering.

Other Information

  • Store at room temperature
  • Avoid excessive heat.

Inactive Ingredients

Citric Acid, Purified water, Sodium phosphate dibasic

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