Povidone Iodine Swabstick

POVIDONE IODINE 10% TOPICAL HUMAN OTC DRUG

Povidone Iodine Swabstick is an FDA drug label for the active ingredient POVIDONE IODINE 10% manufactured by Trifecta Pharmaceuticals USA LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260826.

Generic name
POVIDONE IODINE 10%
Manufacturer
Trifecta Pharmaceuticals USA LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
69396-187
Application
M003
Label effective
20260826

About this product

Povidone Iodine Swabstick is an FDA-registered drug product whose active ingredient is POVIDONE IODINE 10%. It is labelled by Trifecta Pharmaceuticals USA LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69396-187, application M003, label effective 20260826. It is one of 13 FDA drug label records sharing the active ingredient POVIDONE IODINE 10%. 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.

What it is used for

Across FDA labelling, products containing POVIDONE IODINE 10% are most often described in connection with: health care, skin prior, surgery first, aid antiseptic, help prevent, infection minor, cuts scrapes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredient Povidone Iodine USP 10% w/v (equivalent to 1% titratable iodine).

Indications & Usage

Uses Health care antiseptic for preparation of the skin prior to surgery. First Aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns.

Dosage & Administration

Directions For preparation of the skin prior to surgery Clean the affected area Remove swab by stick Apply to the operative site prior to surgery For use as a first aid antiseptic Clean the affected area apply a small amount of this product (equal to the surface area of a fingertip) to the area 1 to 3 times daily. may be covered with a sterile bandage if bandaged let dry first

Warnings

Warnings For external Use Only Do not use in eyes over large areas of the body on individuals who are allergic or sensitive to iodine as a first aid antiseptic longer than 1 week unless directed by a doctor

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How products containing POVIDONE IODINE 10% compare

FDA lists 13 drug label records with POVIDONE IODINE 10% 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.

Dosage formProductsManufacturerProducts
— — Jianerkang Medical Co., Ltd 2
— — Pharma Nobis, LLC 2
— — Chain Drug Consortium 1
— — Chain Drug Market Association 1
— — Discount Drug Mart 1

Frequently asked questions

What is Povidone Iodine Swabstick used for?
Uses Health care antiseptic for preparation of the skin prior to surgery. First Aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns.

Who makes Povidone Iodine Swabstick?
Trifecta Pharmaceuticals USA LLC is the labeler of record for Povidone Iodine Swabstick. 13 FDA label records share the active ingredient POVIDONE IODINE 10%, 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 Swabstick 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 Swabstick 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 10%?
Yes. 13 FDA drug label records list POVIDONE IODINE 10% 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 Swabstick been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.