Active Ingredients
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
The following Structured Product Label (SPL) was submitted to the FDA by Carefusion 213 Llc for the product Chloraprep One-step (NDC 54365-400). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purposes, use, warnings, allergy alert:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Chlorhexidine gluconate 2% w/v
Isopropyl alcohol 70% v/v
Antiseptic
Antiseptic
for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
For external use only.
Flammable, keep away from fire or flame.
• do not use with electrocautery procedures
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.
• 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
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.
irritation, sensitization, or allergic reaction occurs.
These may be signs of a serious condition.
If swallowed, get medical help or contact a Poison Control Center right away.
• 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.
• store between 15-30 °C (59-86 °F)
• avoid freezing and excessive heat above 40 °C (104 °F)
USP purified water
• www.chloraprep.com • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
Principal Display Panel-Package Label
BD ChloraPrep™ FREPP™ Clear
1.5 mL Applicator
2% w/v chlorhexidine gluconate (CHG)
and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
Sterile Solution
Applicator is sterile if package is intact
NDC 54365-400-30
REF 930299
Principal Display Panel-Carton
BD ChloraPrep™ FREPP™ Clear
1.5 mL Applicators
2% w/v chlorhexidine gluconate (CHG)
and 70% v/v isopropyl alcohol (IPA)
Patient Preoperative Skin Preparation
Sterile Solution
Applicator is sterile if package is intact
20 Applicators
NDC 54365-400-30
REF 930299
* Please review the disclaimer below.