Medichoice Pvp Swab
FDA Label NDC 39892-0811

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 (NDC 39892-0811). 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, consult a doctor, stop use and consult a doctor, 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

Active Ingredient

Povidone Iodine USP,10% w/w

Purpose

Antiseptic

Use

For preparation of the skin prior to surgery and helps reduce bacteria that can potentially cause skin infection. 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.

Consult A Doctor

  • in case of deep or puncture wounds, animal bites, or serious burns.

Stop Use And Consult A Doctor

  • if irritation or redness develops 
  • if the condition persists or gets worse 
  • infection occurs.

Keep Out Of Reach Of Children.

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

Directions

For preparation prior to surgery
Clean the treatment area
Remove swab by 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 Ingredient

Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxyno-10, Glycerine, Sodium Hydroxide, Potassium Iodide, Purified Water

Package Labeling:

Label5 (Label5)

Label5 (Label5)

Box4 (Box4)

Box4 (Box4)

Medichoice Pvp Swabsticks, 1000 Count (39892-0811-2)

Label3 (Label3)

Label3 (Label3)

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