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ChloraPrep One-Step by CareFusion 213 LLC

Medically reviewed on September 22, 2017

Dosage form: solution
Ingredients: CHLORHEXIDINE GLUCONATE 20mg in 1mL, ISOPROPYL ALCOHOL 0.7mL in 1mL
Labeler: CareFusion 213 LLC
NDC Code: 54365-400

ChloraPrep® 5.25ml Triple 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 bacteria that potentially can cause skin infection.

Warnings

For external use only. Flammable, keep away from fire or flame.

  • do not use with electrocautery procedures

Allergy alert:

This product may cause a severe allergic reaction.

Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use
  • on patients allergic to chlorhexidine gluconate or any other ingredient in this product
  • 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.
  • maximal treatment area using three swabsticks sequentially is approximately 5 in. x 5 in. (160 cm 2)
  • tear pouch at side notch to reveal applicator handles. 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): using each swabstick sequentially, use gentle repeated back-and-forth strokes for a total of 30 seconds. Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
  • moist surgical sites (e.g., inguinal fold): using each swabstick sequentially, use gentle repeated back-and-forth strokes for a total of 2 minutes. Allow the area to air dry for approximately 1 minute. 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 ingredient

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

PRINCIPAL DISPLAY PANEL-CARTON

5.25ml

TRIPLE

SWABSTICK

APPLICATORS

Clear

Do Not Reuse

Not made with natural rubber latex

40 packages

0.18 fl. oz. (5.25 ml) each

NDC 054365-400-08

Cat. No. 260103

ChloraPrep ®

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-Sterile Solution

Applicator is non-sterile

Professional Use Only

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 DRUGItem 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 
Packaging
#Item CodePackage Description
1NDC:54365-400-0840 POUCH in 1 CARTON
13 APPLICATOR 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/FEIOperations
CareFusion 213 LLC826496312analysis(54365-400), manufacture(54365-400), label(54365-400), pack(54365-400)

 
CareFusion 213 LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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