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

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ChloraPrep® 1.75ml Single Swabstick 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 or injection: 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
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 all 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 and infants under 2 months of age. These products may cause irritation and chemical burns.
use in a well ventilated area
maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm2)
tear pouch at side notch to reveal applicator handle. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
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
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.
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 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

 

Carton Primary Display Panel

Single Swabstick Carton

NDC 054365-400-07

1.75ml SINGLE SWABSTICK APPLICATORS

Clear

Single Use

Latex Free

48 applicators

0.06 fl. oz. (1.75 ml) each

ChloraPrep® One-Step

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
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 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 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 ALCOHOL0.70 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54365-400-0748 in 1 CARTON
11 in 1 POUCH
11.75 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02155505/10/2005
Labeler - CareFusion 213 LLC (826496312)
Registrant - CareFusion 213 LLC (831684456)
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213 LLC826496312ANALYSIS(54365-400), MANUFACTURE(54365-400), LABEL(54365-400), PACK(54365-400)

Revised: 12/2012
Document Id: 0d8d9c21-abfe-4e6b-9fd8-06cc27d2c7a3
Set id: ec074b2e-2898-475c-90d6-d8d0b88440fb
Version: 6
Effective Time: 20121214
 
CareFusion 213 LLC