Drugplain

3M SoluPrep S 20 mg/mL

Chlorhexidine Gluconate and Isopropyl Alcohol · SOLUTION · Solventum US LLC

No Recall History
Plain English

3M Soluprep S is a topical solution containing chlorhexidine gluconate and isopropyl alcohol used to disinfect and prepare skin before medical procedures or injections. This over-the-counter product helps reduce bacteria on the skin surface to help prevent infection.

Key Facts

Brand Name
3M SoluPrep S
Generic Name
Chlorhexidine Gluconate and Isopropyl Alcohol
NDC Code (Product)
17518-083
Manufacturer
Solventum US LLC
Strength
20 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
NDA208288
Marketing Start
01/23/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

hand deformity15 reports
helicobacter infection15 reports
rheumatoid arthritis15 reports
swelling15 reports
systemic lupus erythematosus15 reports
glossodynia14 reports
infusion related reaction14 reports
joint swelling14 reports
synovitis14 reports
wound14 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

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

Frequently Asked Questions

What is 3M SoluPrep S used for?

3M Soluprep S is a topical solution containing chlorhexidine gluconate and isopropyl alcohol used to disinfect and prepare skin before medical procedures or injections. This over-the-counter product helps reduce bacteria on the skin surface to help prevent infection.

Is 3M SoluPrep S a controlled substance?

3M SoluPrep S is not classified as a controlled substance by the DEA.

What is the generic name for 3M SoluPrep S?

The generic name for 3M SoluPrep S is Chlorhexidine Gluconate and Isopropyl Alcohol. There are 5 other brand versions of Chlorhexidine Gluconate and Isopropyl Alcohol.

What is the NDC code for 3M SoluPrep S 20 mg/mL?

The NDC (National Drug Code) for 3M SoluPrep S 20 mg/mL is 17518-083, listed by Solventum US LLC.

Product NDC

17518-083

Package NDC

17518-083-02

Other 3M SoluPrep S Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)