Povidone-iodine Solution
FDA Label NDC 53329-939

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Povidone-iodine (NDC 53329-939). 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, 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% available 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
  • longer than 1 week unless directed by a doctor
  • on individuals who are allergic or sensitive to iodine
  • or apply over large areas of the body

Stop Use And Ask A Doctor

  • if irritation and redness develop
  • if condition persists for more than 72 hours
  • in case of deep or puncture wounds, animal bites or serious burns

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 prior to surgery
  • For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water.

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