CHLORAPREP ONE-STEP - chlorhexidine gluconate and isopropyl alcohol solution
CareFusion 213 LLC

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ChloraPrep® Hi-Lite Orange® 26ml Applicator

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 risk of fire; PREP CAREFULLY:

do not use 26-mL applicator for head and neck surgery
do not use on an area smaller than 8.4 in. x 8.4 in. Use a small applicator instead.
solution contains alcohol and gives off flammable vapors
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).
avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
do not allow solution to pool
remove wet materials from prep area

Do not use

in children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption
on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
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

before using this product see insert for important information
to reduce the risk of fire the following strategies are recommended:
- at the end of prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available.
- use in a well ventilated area
- avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
- do not allow solution to pool
- tuck prep towels to absorb solution, and then remove
- remove wet materials from prep area
- drape after solution is completely dry
maximal treatment area for one applicator is approximately 13.2 in. x 13.2 in. (1126 cm2). Discard the applicator after a single use.
pinch the wing on the applicator to break the ampule and release the antiseptic. Do not touch the sponge. Wet the sponge by repeatedly pressing and releasing the sponge against the treatment area until liquid is visible on the skin.
dry surgical sites (such as abdomen or arm): Use repeated back-and-forth strokes of the sponge for approximately 30 seconds. Completely wet the treatment area with antiseptic. Allow the area to air dry for approximately three (3) minutes. Do not blot or wipe away.
moist surgical sites (such as the inguinal fold): Use repeated back-and-forth strokes of the sponge for approximately 2 minutes. Completely wet the treatment area with antiseptic. Allow the area to air dry for approximately three (3) minutes. Do not blot or wipe away.

Other information

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

Inactive ingredients

FD&C yellow #6 dye
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

26ml Orange Carton Primary Display Panel

26ml Hi-Lite Orange Primary Display

Cat. No. 260815

NDC 054365-400-13

ChloraPrep® With Tint

2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol

Patient Preoperative Skin Preparation

26ml APPLICATOR

Hi-Lite Orange®

WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

Single Use

Applicator is STERILE if package is intact

CareFusion, Leawood, KS 66211

Artwork No. 6-786815

I0310

Made in USA

CHLORAPREP ONE-STEP
chlorhexidine gluconate and isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	54365-400
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE)	CHLORHEXIDINE GLUCONATE	20 mg in 1 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL)	ISOPROPYL ALCOHOL	0.7 mL in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
FD&C YELLOW NO. 6

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	54365-400-13	1 APPLICATOR In 1 POUCH	contains a APPLICATOR
1		26 mL In 1 APPLICATOR	This package is contained within the POUCH (54365-400-13)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020832	08/18/2006

Labeler - CareFusion 213 LLC (830430810)

Registrant - CareFusion 213 LLC (831684456)

Establishment
Name	Address	ID/FEI	Operations
CareFusion 213 LLC		830430810	ANALYSIS, MANUFACTURE, LABEL, PACK

Revised: 12/2010CareFusion 213 LLC