3M DuraPrep Surgical

3M DuraPrep Surgical is an FDA-registered drug product whose active ingredient is IODINE POVACRYLEX AND ISOPROPYL ALCOHOL. It is labelled by Solventum US LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 17518-011, application NDA021586, label effective 20260423. 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 IODINE POVACRYLEX AND ISOPROPYL ALCOHOL are most often described in connection with: patient preoperative, skin preparation, prior surgery, helps reduce. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection

Directions (follow all directions for use) at the end of the prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery. If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: grasp product by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever. with sponge face parallel to the floor, snap lever. Allow all fluid to flow into sponge. When Applying Solution: DO NOT SCRUB . Paint a single, uniform application and do not reprep area. do not allow solution to pool . Use sponge applicator to absorb excess solution and continue to apply a uniform coating. If solution accidentally gets outside of prep area, remove excess with gauze. tuck prep towels as needed under both sides of the neck to absorb excess solution. Remove towels before draping. avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. Otherwise, skin may adhere to itself. After Applying Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) . Solution will turn from a shiny to a dull appearance on skin alerting the user that the solution is completely dry and no longer flammable. While Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution. Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin. remove solution-stained materials. Replace if necessary. After Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all solution-stained materials are removed if incise drapes are used, apply directly to dry prep. On completion of surgical procedure, removal of incise drape will remove film. apply dressing following standard practices

Warnings For external use only. Flammable, keep away from fire or flame. To reduce the risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors 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). avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. do not allow solution to pool remove solution-stained material from prep area Do not use on patients with known allergies to iodine or any other ingredients in this product on open wounds, on mucous membranes, or as a general skin cleanser in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism When using this product keep out of eyes, ears, and mouth. May cause serious injury if permitted to enter and remain. If contact occurs, flush with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc…applied over film use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. On rare occasions, use of this product has been associated with skin blistering. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.

What is 3M DuraPrep Surgical used for?
Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection

Who makes 3M DuraPrep Surgical?
Solventum US LLC is the labeler of record for 3M DuraPrep Surgical.

What form does 3M DuraPrep Surgical 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 3M DuraPrep Surgical 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.

Has 3M DuraPrep Surgical 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.