3M SoluPrep S Chlorhexidine Gluconate and Isopropyl Alcohol 20 mg/mL; .7 mL/mL Solution
Other active recalls for Chlorhexidine Gluconate And Isopropyl Alcohol (different manufacturers) — 6 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Antiinfectives and antiseptics for local oral treatment class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- It's an antiseptic skin prep used before surgery or an injection. A healthcare provider applies it to clean the skin and kill bacteria at the site so you're less likely to get an i...
- What is this solution actually used for?
- Because these solutions contain alcohol, which is flammable. If surgical tools that produce heat — like cautery devices or lasers — are used before the solution is fully dry, there...
- Why does the prep area have to dry before the surgery starts?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| 3M SoluPrep S 20 mg/mL; .7 mL/mLthis 17518-0082-01 | Solventum | 1 applicator | — | — | FDA listed | — |
| 3M SoluPrep S 20 mg/mL; .7 mL/mL 17518-0083-02 | Solventum | 1 applicator | — | — | FDA listed | — |
| ChloraPrep One-Step 20 mg/mL; .7 mL/mL 54365-0400-07 | CareFusion | 48 pouches | — | — | FDA listed | — |
| ChloraPrep Swabstick 20 mg/mL; .7 mL/mL 54365-0401-28 | CareFusion | 48 pouches | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Code | What it grants | Expires |
|---|---|---|
| M-292 | New indication / labeling change (3-year) | Jan 20, 2026 |
Is there a generic version of this drug?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 17518-0082-01 You're viewing this | 1 APPLICATOR in 1 POUCH (17518-082-01) / 26 mL in 1 APPLICATOR | 2023-01-23 | Active |
| 17518-0082-02 | 1 APPLICATOR in 1 POUCH (17518-082-02) / 10.5 mL in 1 APPLICATOR | 2023-01-23 | Active |
Pack size FAQ
What quantity is in NDC 17518-0082-01?
What NDC number is used to bill for this package of 3M SoluPrep S Chlorhexidine Gluconate and Isopropyl Alcohol 20 mg/mL; .7 mL/mL Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
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
Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection
⏱️ Dosage and 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
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 ▾
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.
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…
🧪 Active Ingredient ▾
Active 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
🧪 Inactive Ingredients ▾
Inactive ingredients acetyltri-n-butyl citrate, FD&C blue #1, FD&C yellow #5, purified water USP, Trisodium HEDTA
Inactive ingredients acetyltri-n-butyl citrate, FD&C blue #1, FD&C yellow #5, purified water USP, Trisodium HEDTA
Inactive ingredients acetyltri-n-butyl citrate, purified water USP, Trisodium HEDTA
🎯 Purpose ▾
Purpose Antiseptic Antiseptic
Purpose Antiseptic Antiseptic
Purpose Antiseptic Antiseptic