On this page
3M SoluPrep S
Chlorhexidine Gluconate and Isopropyl Alcohol · Solution
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Chlorhexidine Gluconate | 20 mg/mL | 1667684 | View |
| Isopropyl Alcohol | .7 mL/mL | 797544 | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Cell Wall Integrity [PE] | PE | All 26 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 208288-001 | SOLUPREP S | SOLUTION | CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Patents and exclusivity
Source: Orange Book| Code | Expires | Product |
|---|---|---|
| M-292 | January 20, 2026 | 001 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 4 | Efficacy | Approved | January 20, 2023 | Standard |
| Original application | 1 | Type 5 - New Formulation or New Manufacturer | Approved | August 8, 2018 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260423). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection
Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection
Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection
Purpose
openFDA Drug LabelingPurpose Antiseptic Antiseptic
Purpose Antiseptic Antiseptic
Purpose Antiseptic Antiseptic
Dosage and Administration
openFDA Drug LabelingDirections (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
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 grasp products 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 to allow fluid 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 8.4 in. x 15.6 in. (131.4 in 2 ). do not allow solution to pool ; tuck prep towels to absorb solution, and then remove 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 u …
Warnings
openFDA Drug LabelingWarnings 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.
Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: 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.
Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: 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 ou …
Do Not Use
openFDA Drug LabelingDo 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
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
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
Stop Use
openFDA Drug LabelingStop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Active Ingredient
openFDA Drug LabelingActive ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v
Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v
Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ISOPROPYL ALCOHOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 17518-082-01 | 17518-082 | Solventum US LLC | 1 APPLICATOR in 1 POUCH (17518-082-01) / 26 mL in 1 APPLICATOR | January 23, 2023 |
| 17518-082-02 | 17518-082 | Solventum US LLC | 1 APPLICATOR in 1 POUCH (17518-082-02) / 10.5 mL in 1 APPLICATOR | January 23, 2023 |
| 17518-083-02 | 17518-083 | Solventum US LLC | 1 APPLICATOR in 1 POUCH (17518-083-02) / 10.5 mL in 1 APPLICATOR | January 23, 2023 |
| 17518-082 | 17518-082 | Solventum US LLC | — | January 23, 2023 |
| 17518-083 | 17518-083 | Solventum US LLC | — | January 23, 2023 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.