chlorhexidine gluconate and isopropyl alcohol (ChloraPrep One-Step) Drug Information

ChloraPrep One-Step

chlorhexidine gluconate and isopropyl alcohol

ISOPROPYL ALCOHOL

WATER

CHLORHEXIDINE GLUCONATE

CHLORHEXIDINE

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Purposes

Antiseptic

Use

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. 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

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.

Do not use

on patients with known allergies 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

When using this product

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.

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 too 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.

Other information

store between 15-30 °C (59-86 °F)
avoid freezing and excessive heat above 40 °C (104 °F)

Inactive ingredients

USP purified water

Questions?

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

Package/Label Principal Display Panel

ChloraPrep 3 mL Clear

PRINCIPAL DISPLAY PANEL-CARTON

3 ml

APPLICATORS

Clear

Do Not Reuse

Not made with natural rubber latex

STERILE EO

Professional Use Only

Store between 15-30 °C (59-86 °F)

Avoid freezing and excessive heat

above 40 °C (104 °F)

25 applicators

0.10 fl. oz. (3 ml) each

NDC 054365-400-01

Cat. No. 260400

ChloraPrep® One-Step

2% w/v chlorhexidine gluconate (CHG)

and 70% isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is sterile if package is intact

WARNING

FLAMMABLE

Keep away from fire or flame.

To reduce 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

54365-400-11