Povidone-iodine Solution
FDA Label NDC 0924-5408

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Povidone-iodine (NDC 0924-5408). 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 ingredients (each swab), 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 Ingredients (Each Swab)

10% Povidone Iodine Solution USP, (1% available Iodine)

Purpose

Topical Antiseptic

Uses

First Aid Antiseptic To Help prevent infection in minor skin cuts and abrasions and burns.

Warnings

For external use only.

Do not use in the eyes; if you are allergic to any of the ingredients; longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have• deep or puncture wounds • serious burns

Stop use and ask a doctor if • redness, irritation, swelling or pain persists or increases
• infection occurs.

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.

Directions

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury. Discard after single use.

Other Information

Store at room temperature away from light. Keep from freezing or excessive heat.

Inactive Ingredients

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

Questions?

Call 1-800.835.2263

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