ChloraPrep One-Step 20 mg/mL
chlorhexidine gluconate and isopropyl alcohol · SOLUTION · CareFusion 213, LLC
ChloraPrep One-Step is a prescription solution containing chlorhexidine gluconate and isopropyl alcohol at 20 mg/mL, taken topical. Manufactured by CareFusion 213, LLC.
Key Facts
- Brand Name
- ChloraPrep One-Step
- Generic Name
- chlorhexidine gluconate and isopropyl alcohol
- NDC Code (Product)
54365-400- Manufacturer
- CareFusion 213, LLC
- Strength
- 20 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- HUMAN OTC DRUG
- Application #
- NDA020832
- Drug Class
- Decreased Cell Wall Integrity [PE]
- Marketing Start
- 05/24/2019
Recall History
CareFusion 213, LLC
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Carefusion 213, Llc
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
CareFusion 213, LLC
CGMP Deviations: 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, resulting in a breach of the package integrity.
CareFusion 213, LLC
Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Dosage & Administration
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.
Warnings
Warnings For external use only. Flammable, keep away from fire or flame. • do not use with electrocautery procedures
Frequently Asked Questions
What is ChloraPrep One-Step used for?
ChloraPrep One-Step contains chlorhexidine gluconate and isopropyl alcohol. It is a solution taken topical. Consult your doctor for specific uses.
Is ChloraPrep One-Step a controlled substance?
ChloraPrep One-Step is not classified as a controlled substance by the DEA.
What is the generic name for ChloraPrep One-Step?
The generic name for ChloraPrep One-Step is chlorhexidine gluconate and isopropyl alcohol. There are 6 other brand versions of chlorhexidine gluconate and isopropyl alcohol.
What is the NDC code for ChloraPrep One-Step 20 mg/mL?
The NDC (National Drug Code) for ChloraPrep One-Step 20 mg/mL is 54365-400, listed by CareFusion 213, LLC.