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

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ChloraPrep® 5.25ml Triple Swabstick 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 bacterial 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:

solution contains alcohol and gives off flammable vapors
do not use with ignition source (e.g. cautery, laser)
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 all 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

to reduce risk of fire the following strategies are recommended:
- do not use with ignition source (e.g. cautery, laser)
- 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 using three swabsticks is approximately 5 in. x 5 in. (160 cm2). Discard the swabsticks after a use.
tear pouch at notch. Pull across package to expose the ends of the swabsticks. Do not touch foam when removing swabstick from pouch. Place foam flat side down on the treatment area.
dry surgical sites (such as abdomen or arm): Using each swabstick sequentially, apply within the entire coverage area using gentle back-and-forth strokes. The total application time for all three swabsticks is approximately 30 seconds. Allow the area to air dry for approximately one (1) minute . Do not blot or wipe away.
moist surgical sites (such as inguinal fold): Using each swabstick sequentially, apply within the entire coverage area using gentle back-and-forth strokes. The total application time for all three swabsticks is approximately two (2) minutes. Allow the area to air dry for approximately one (1) minute. Do not blot or wipe away.

Other information

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

Triple Swabstick Carton Primary Display Panel

NDC 054365-400-08

5.25ml TRIPLE SWABSTICK APPLICATORS

Clear

Single Use

Latex Free

40 packages

0.18 fl. oz. (5.25 ml) each

ChloraPrep®

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

Patient Preoperative Skin Preparation

WARNING FLAMMABLE

Keep away from fire or flame.

To reduce risk of fire, PREP CAREFULLY:

solution contains alcohol and gives off flammable vapors
do not use with ignition source (e.g. cautery, laser)
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 material from prep area

Store between 15-30 ºC (59-86 ºF)

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

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	0.70 mL in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	54365-400-08	40 POUCH In 1 CARTON	contains a POUCH
1		3 APPLICATOR In 1 POUCH	This package is contained within the CARTON (54365-400-08) and contains a APPLICATOR
1		1.75 mL In 1 APPLICATOR	This package is contained within a POUCH and a CARTON (54365-400-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021555	05/10/2005

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