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

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ChloraPrep® Hi-Lite Orange® 10.5ml Applicator

Active ingredients

Chlorhexidine gluconate 2% w/v

Isopropyl alcohol 70% v/v

Purposes

Antiseptic

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 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

Do not use

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

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 8.4 in. x 8.4 in. (457 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 for 30 seconds
moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes
do not allow solution to pool; tuck prep towels to absorb solution, and then remove
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.do not allow solution to pool
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)
the tint will slowly fade from the skin. Soap and water, or alcohol may be used to remove the tint if desired.

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

Carton Front Panel, 10.5ml Orange

NDC 054365-400-12

10.5ml APPLICATORS

Hi-Lite Orange®

Not made with natural rubber latex

Applicator is sterile if package is intact

Store between 15-30 °C (59-86 °F)

Avoid freezing and excessive heat above 40 °C (104 °F)

25 applicators

0.36 fl. oz. (10.5 ml) each

CHLORAPREP ONE-STEP 
chlorhexidine gluconate and isopropyl alcohol solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54365-400
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54365-400-12 25 in 1 CARTON
1 1 in 1 POUCH
1 10.5 mL in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020832 08/18/2006
Labeler - CareFusion 213 LLC (826496312)
Registrant - CareFusion 2200, Inc (832696038)
Establishment
Name Address ID/FEI Business Operations
CareFusion 213 LLC 826496312 ANALYSIS(54365-400) , MANUFACTURE(54365-400) , LABEL(54365-400) , PACK(54365-400)

Revised: 11/2013
Document Id: 4c91e48d-33fe-46b9-9000-2e2dbbfd01aa
Set id: 77a8858e-2b3e-4b13-83ed-c989b7cc554c
Version: 7
Effective Time: 20131115
 
CareFusion 213 LLC