Your browser does not support JavaScript! CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) SOLUTION [CAREFUSION 213 LLC]
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CHLORAPREP ONE-STEP (chlorhexidine gluconate and isopropyl alcohol) solution
[CareFusion 213 LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

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 cm2)
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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54365-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54365-400-1225 in 1 CARTON
11 in 1 POUCH
110.5 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083208/18/2006
Labeler - CareFusion 213 LLC (826496312)
Registrant - CareFusion 2200, Inc (832696038)
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213 LLC826496312ANALYSIS(54365-400), MANUFACTURE(54365-400), LABEL(54365-400), PACK(54365-400)

Revised: 11/2013
 
CareFusion 213 LLC

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