3M SoluPrep S

CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL TOPICAL HUMAN OTC DRUG

3M SoluPrep S is an FDA drug label for the active ingredient CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL manufactured by Solventum US 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 20260423.

Generic name
CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
Manufacturer
Solventum US LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
17518-082
Application
NDA208288
Label effective
20260423

About this product

3M SoluPrep S is an FDA-registered drug product whose active ingredient is CHLORHEXIDINE GLUCONATE 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 17518-082, application NDA208288, label effective 20260423. It is one of 4 FDA drug label records sharing the active ingredient CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL. 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 CHLORHEXIDINE GLUCONATE 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.

Active ingredients

Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/vActive ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/vActive ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v

Indications & Usage

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

Dosage & Administration

Directions (follow all directions for use) use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. discard the applicator after a single use along with any portion of the solution not required to cover the prepped 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: remove applicator from package; do not touch sponge with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into sponge. When Applying Solution: completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes maximal treatment area for one applicator is approximately 13.2 in. x 21.6 in. (285.2 in 2 ). do not allow solution to pool ; tuck prep towels to absorb solution, and then remove clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.) 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. 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) 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 wet materials from prep area. 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 wet materials are removed if incise drapes are used, apply directly to dry prep apply dressing following standard practices

Warnings

Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: do not use 26-mL applicator for head and neck surgery do not use on an area smaller than 8.4 in. x 15.6 in. Use a smaller applicator instead. solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. 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 Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use on patients with known allergies to chlorhexidine gluconate or any other ingredient in this product 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. to avoid skin injury, care should be taken when removing drapes, tapes, etc. 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.

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How products containing CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL compare

FDA lists 4 drug label records with CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL 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
— — Professional Disposables International, Inc. 3
— — Solventum US LLC 1
— — — —
— — — —
— — — —

Frequently asked questions

What is 3M SoluPrep S 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 SoluPrep S?
Solventum US LLC is the labeler of record for 3M SoluPrep S. 4 FDA label records share the active ingredient CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL, 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 3M SoluPrep S 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 SoluPrep S 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 CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL?
Yes. 4 FDA drug label records list CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL 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 3M SoluPrep S 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.