Povidone-iodine Solution
FDA Label NDC 0904-7639

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Povidone-iodine (NDC 0904-7639). 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 other, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, stop use and consult a doctor if, when using this product do not, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredient

Povidone-Iodine 10%

(Equivalent to 1% titrable iodine)

Purpose

First Aid Antiseptic

Uses

First aid antiseptic to prevent infection in minor cuts, scrapes and burns.

Warnings

For External Use Only

Ask A Doctor Before Use If You Have

  • deep puncture wounds
  • animal bites
  • serious burns

Stop Use And Consult A Doctor If

  • the condition persists or gets worse
  • irritation and redness develop and persists for more than 72 hours

When Using This Product Do Not

  • use in eyes
  • use on individuals who are allergic or sensitive to iodine or use for longer than 1 week unless directed by a doctor
  • apply over large areas of the body

Keep Out Of Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222).

Directions

Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If bandaged, let it dry first.

Other Information

store at room temperature, 20-25C (68-77F)

Inactive Ingredients

Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

* Please review the disclaimer below.