ChloraPrep One-Step
Chlorhexidine gluconate and isopropyl alcohol · Solution · Topical
Active ingredient
Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v
Purpose
Purposes Antiseptic Antiseptic
Uses
Use for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Warnings
Warnings For external use only. Flammable, keep away from fire or flame.
• do not use with electrocautery procedures 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
Do not use
• on patients allergic 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
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.
Stop use and ask a doctor
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
• use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
• maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2 )
• remove applicator from package; do not touch sponge
• hold the applicator horizontally with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic.
• wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin
• completely wet the treatment area with antiseptic
• dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds. Allow the area to air dry for approximately 30 seconds.
• moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes. Allow the area to air dry for approximately 1 minute.
• do not blot or wipe away
• discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.
Inactive ingredients
Inactive Ingredient USP purified water
Questions?
Questions?
• www.chloraprep.com
• call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
Label text from the FDA structured product label by CareFusion 213, LLC (revised Nov 3, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Chlorhexidine Gluconate in 1 product
- Isopropyl Alcohol in 1 product
ChloraPrep One-Step NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 54365-400 | Chlorhexidine Gluconate 20 mg/mL; Isopropyl Alcohol .7 mL/mL Solution | CareFusion 213, LLC | NDA |
ChloraPrep One-Step recalls
- D-0690-2026 Jul 22, 2026 · Class II · Ongoing
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator - D-0652-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0651-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0650-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0649-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0648-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0647-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0646-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0645-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0643-2026 Jul 8, 2026 · Class II · Ongoing
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel - D-0624-2026 Jul 1, 2026 · Class I · Ongoing
Non-Sterility: Due to presence of Aspergillus penicillioides. - D-0625-2026 Jul 1, 2026 · Class I · Ongoing
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 seal area. - D-0623-2026 Jul 1, 2026 · Class II · Ongoing
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - D-0622-2026 Jul 1, 2026 · Class II · Ongoing
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. - D-0441-2025 May 28, 2025 · Class II · Ongoing
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator. - D-0259-2025 Mar 19, 2025 · Class I · Ongoing
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. - D-1168-2023 Sep 27, 2023 · Class II · Completed
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate… - D-0373-2021 May 19, 2021 · Class I · Terminated
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution. - D-0348-2021 May 5, 2021 · Class II · Terminated
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus,… - D-0347-2021 May 5, 2021 · Class II · Terminated
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus,…
Frequently asked questions
What is ChloraPrep One-Step used for?
Use for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Who makes ChloraPrep One-Step?
ChloraPrep One-Step is listed by 1 labeler in the FDA NDC directory, including CareFusion 213, LLC.
Has ChloraPrep One-Step been recalled?
The FDA enforcement database lists 20 recalls for ChloraPrep One-Step, most recently D-0690-2026 (class ii): Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator