Povidone-iodine Solution
FDA Label NDC 50332-0056

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Povidone-iodine (NDC 50332-0056). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, 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% (available iodine 1%)

Purpose

Topical antiseptic

Uses

First aid topical antiseptic to help prevent infection in

  • minor cuts
  • scrapes
  • abrasions

Warnings

For external use only.

  • do not get in eyes

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If swallowed, get medical help immediately or contact a Poison Control Center right away. 1-800-222-1222

Directions

Adults and children 12 years of age and older:

  • reverse cardboard sleeve
  • crush at dot between thumb and forefinger to release fluid
  • gently wipes injured area to clean and disinfect
  • dispose of swab peoperly
  • do not reuse swab

    • Children under 12 years of age: ask a doctor

Other Information

 Store at room temperaturem 59° - 86°F (15° - 30°C) away from light. Keep from freezing or excessive heat.

Inactive Ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

Packaging

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