Medichoice Pvp Prep Solution
FDA Label NDC 39892-0842

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 Prep (NDC 39892-0842). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, stop use and consult a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Povidone-Iodine, USP 10% (equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

  • Healthcare antiseptic for preparation of the skin prior to surgery.
  • First aid antiseptic to help prevent 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 first aid antiseptic longer than 1 week unless directed by doctor.

Stop Use And Consult A Doctor If

  • you have deep or puncture wounds
  • animal bites
  • serious burns 
  • the condition persists or gets worse
  • irritation and redness develop

Keep Out Of Reach Of Children.

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

Directions

  • Clean the affected area
  • for preparation of the skin prior to surgery, apply product to the operative site
  • for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

Store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

citric acid monohydrate, sodium phosphate dibasic dihydrate, water

Package Labeling:

Label3 (Label3)

Label3 (Label3)

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