Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)

Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) is an FDA-registered drug product whose active ingredient is POVIDONE-IODINE. It is labelled by XINXIANG XINDA TECHNOLOGY CO.,LTD taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84128-007, application M003, label effective 20260514. 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: patient skin, prior surgery, helps reduce. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Directions Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Use in a well ventilated area Maximal treatment area for one applicator is approximately 4 in. x 5 in. (129 cm²). Do not use 3-ml applicator for head and neck surgery Remove applicator from package; do not touch sponge hold the applicator with the sponge down. Open the switch only once to activate the ampules and release the antiseptic. Wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin Completely wet the treatment area with antiseptic Dry surgical sites(e.g. abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds Moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes Do not allow solution to pool; tuck prep towels to absorb solution, and then remove Allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. Discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

Warnings For external use only. PREP CAREFULLY: Do not use 3-ml applicator for head and neck surgery Do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) Do not allow solution to pool Remove wet materials from prep area Do not use On patients with known allergies to chlorhexidine gluconate or isopropyl alcohol For lumbar puncture or in contact with the meninges On open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. 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.

What is Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) used for?
Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Who makes Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)?
XINXIANG XINDA TECHNOLOGY CO.,LTD is the labeler of record for Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP). 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 Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) 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 Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) 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 Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP) 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.