Povidone-Iodine Topical Antiseptic

Povidone-Iodine Topical Antiseptic is an FDA-registered drug product whose active ingredient is POVIDONE-IODINE. It is labelled by Medline Industries, LP taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 53329-939, application 505G(a)(3), label effective 20260828. It is one of 58 FDA drug label records sharing the active ingredient POVIDONE-IODINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing POVIDONE-IODINE are most often described in connection with: healthcare antiseptic, skin prior, surgery first, help prevent, infection minor, cuts scrapes, burns single, patient preoperative. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses healthcare antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent infection in minor cuts, scrapes and burns single use when used for patient preoperative skin preparation

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.

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 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.

FDA lists 58 drug label records with POVIDONE-IODINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Povidone-Iodine Topical Antiseptic used for?
Uses healthcare antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent infection in minor cuts, scrapes and burns single use when used for patient preoperative skin preparation

Who makes Povidone-Iodine Topical Antiseptic?
Medline Industries, LP is the labeler of record for Povidone-Iodine Topical Antiseptic. 58 FDA label records share the active ingredient POVIDONE-IODINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Povidone-Iodine Topical Antiseptic come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Povidone-Iodine Topical Antiseptic prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing POVIDONE-IODINE?
Yes. 58 FDA drug label records list POVIDONE-IODINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Povidone-Iodine Topical Antiseptic been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.