Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution

KEEP AWAY FROM FIRE OR FLAME.

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. To reduce the risk of

fire, PREP CAREFULLY:

• solution contains alcohol and gives off flammable vapors
• avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
• do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless

skin; up to 1 hour in hair)

• do not allow solution to pool
• remove wet materials from prep area

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.

• use in a well ventilated area

• maximal treatment area for one applicator is approximately 4 in. x 5 in. (130 cm 2)

• 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 of the sponge for approximately 30 seconds. Allow solution to air dry for approximately 30 seconds. Do not blot or wipe away.

• moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes of the sponge for approximately 2 minutes. Allow solution to air dry for approximately 1 minute. Do not blot or wipe away.

• If using an ignition source, allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). 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 oC (59-86 oF)

• avoid freezing and excessive heat above 40 oC (104 oF)

FD&C yellow #6 dye, USP purified water

www.chloraprep.com • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

Principal Display Panel-Carton

BD ChloraPrep™ Hi-Lite Orange™

3 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

Store between 15-30 oC (59-86 oF)

Avoid freezing and excessive heat above 40 oC (104 oF)

0.10 fl.oz. (3 mL) each

25 Applicators

NDC 54365-400-33

REF 930415