Chloraprep One-Step
.7 mL/mL + 20 mg/mL · Solution
- Available without prescription
- Active substance
- Chlorhexidine Gluconate and Isopropyl Alcohol
- Made by
- CareFusion 213, LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-11-04
- Class II Ongoing · 2026-07-09 — Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicatorUsing the product could cause temporary or medically reversible harm.
- Class II Ongoing · 2026-06-11 — 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 channelUsing the product could cause temporary or medically reversible harm.
- Class II Ongoing · 2026-06-11 — 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 channelUsing the product could cause temporary or medically reversible harm.
A recall usually covers specific lots. Check the lot number on your pack against the notice, and ask your pharmacist before you stop a medicine. FDA recalls
Antiseptic Antiseptic
- For the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
On patients allergic to chlorhexidine gluconate or any other ingredient in this product
All warnings ↓- Sold without a prescription
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
From the official label · 2025-11-04 · DailyMed
Do not take it if
- 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
Quoted from the official label, section “OTC — Do Not Use”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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 cm2) remove applicator from package; do not touch sponge hold the applicator 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 approximately 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 approximately 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.
Quoted from the official label, section “Dosage & Administration”.
Stop and get help if
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
Quoted from the official label, section “OTC — Stop Use”.
Other 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.
- 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.
Quoted from the official label, section “Warnings”.
Keep away from children
If swallowed, get medical help or contact a Poison Control Center right away.
Quoted from the official label, section “OTC — Keep Out of Reach of Children”.
How to store it
- store between 15-30 °C (59-86 °F)
- avoid freezing and excessive heat above 40 °C (104 °F)
Quoted from the official label, section “Storage and Handling”.
What kind of medicine it is
Antiseptic Antiseptic
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
USP purified water
Quoted from the official label, section “Inactive Ingredients”.
Questions about this product
- www.chloraprep.com
- call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
Quoted from the official label, section “OTC — Questions”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | CareFusion 213, LLC |
|---|---|
| Active substance | Chlorhexidine Gluconate and Isopropyl Alcohol |
| Strength | .7 mL/mL + 20 mg/mL |
| Form | Solution |
| Route | Topical |
| Packs | 48 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR · 40 POUCH in 1 CARTON / 3 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR |
| NDC | 54365-400 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution3 products
- .7 mL/mL + 20 mg/mL
20 mg/mL + .7 mL/mL2
20 mg/mL + .7 mL/mL · 2 companies
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
See every product with Chlorhexidine Gluconate and Isopropyl Alcohol