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FDA LABEL GENERIC: Chlorhexidine MFR: CareFusion 213, LLC

Chloraprep (chlorhexidine Gluconate 2 % / Isopropyl Alcohol 70 % ) Topical Solution

Table of Contents

INDICATIONS AND USAGE
WARNINGS
WARNINGS
DOSAGE AND ADMINISTRATION
ASK A DOCTOR
ASK A DOCTOR

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Antiseptic

INDICATIONS AND USAGE

for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

WARNINGS

For external use only.

Flammable, keep away from fire or flame.

• do not use with electrocautery procedures

WARNINGS

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.

DOSAGE AND ADMINISTRATION

• 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)

ASK A DOCTOR

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