Over-the-counter medicine
Chlorhexidine and isopropyl alcohol Brand names: Chloraprep, Prevantics; first approved as Chloraprep One-Step
Chlorhexidine and isopropyl alcohol (Chloraprep) is an over-the-counter medicine with an FDA approval on record since 2000. No generic is listed in FDA's NDC Directory.
- No generic listed
- Over the counter
Check it at the source: the chlorhexidine and isopropyl alcohol FDA label on DailyMed (effective April 23, 2026, Solventum US LLC); the NDA 20832 record on Drugs@FDA; every chlorhexidine and isopropyl alcohol label on DailyMed.
Highlights of the record
FDA label of April 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagepatient 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 pot
Forms and strengths
- 0.7 ml/ml / 20 mg/ml
- 20 mg/ml / 0.7 ml/ml
- 31.5 mg/ml / 0.7 ml/ml
Solution.
On the market
- Earliest approval on file
- July 14, 2000 Chloraprep One-Step, Becton Dickinson Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 5 of which 0 under generic applications, 5 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
- Last listed patent
- April 25, 2027 Chloraprep One-Step sponge; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 30 since 2012 9 Class I among all firms' recalls; latest July 9, 2026
- FAERS reports
- 301 through July 30, 2026
What is chlorhexidine and isopropyl alcohol used for?
From the label: indications and usagepatient 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
Source: FDA drug label (3M SoluPrep S), Solventum US LLC, effective April 23, 2026 (SPL set 084aa305-5863-441a-a94d-36bc1b05195a), via openFDA; the full label on DailyMed
Is there a generic for chlorhexidine and isopropyl alcohol (Chloraprep)?
No generic chlorhexidine and isopropyl alcohol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists no patent for Chloraprep One-Step Sepp swab; a patent listed only for Chloraprep One-Step sponge runs to April 25, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has chlorhexidine and isopropyl alcohol been recalled?
The FDA's Enforcement Report lists 30 recalls naming chlorhexidine and isopropyl alcohol since 2012: 9 Class I (the most serious), 21 Class II, 0 Class III; 17 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 9, 2026 | Class II | CareFusion 213, LLC | Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator |
| June 11, 2026 | Class II | CareFusion 213, LLC | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to … |
| May 28, 2026 | Class II | CareFusion 213, LLC | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. |
| May 28, 2026 | Class I | CareFusion 213, LLC | Non-Sterility: Due to presence of Aspergillus penicillioides. |
| May 28, 2026 | Class I | CareFusion 213, LLC | Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the … |
| December 17, 2025 | Class II | CareFusion 213, LLC | Lack of Assurance of Sterlity |
| May 15, 2025 | Class II | CareFusion 213, LLC | Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. |
| February 14, 2025 | Class I | CareFusion 213, LLC | Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for chlorhexidine and isopropyl alcohol?
The FDA Adverse Event Reporting System holds 301 reports that list chlorhexidine and isopropyl alcohol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 29 are coded as a death and 78 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Chlorhexidine and isopropyl alcohol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other