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ChloraPrep One-Step by CareFusion 213 LLC

Medically reviewed on Sep 27, 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® Frepp® Drug Facts

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 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 occurrs, 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 and infants under 2 months of age. These products may cause irritation or chemical burns.
  • maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
  • remove applicator from package; do not touch sponge
  • hold the applicator horizontally 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. Allow the area to air dry for approximately 30 seconds.
  • moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 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 °C (59-86 °F)
  • avoid freezing and excessive heat above 40 °C (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

PRINCIPAL DISPLAY PANEL-CARTON

1.5ml

FREPP ®

APPLICATORS

Clear

Do Not Reuse

Not made with natural rubber latex

STERILE EO

20 applicators

0.05 fl. oz. (1.5ml) each

NDC 054365-400-02

Cat. No.260299

ChloraPrep ® One-Step

2% w/v chlorhexidine gluconate (CHG)

and 70% v/v isopropyl alcohol (IPA)

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is sterile if package is intact

Professional Use Only

Store between 15-30 °C (59-86 °F)

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

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:54365-400-0220 POUCH in 1 CARTON
11 APPLICATOR in 1 POUCH
11.5 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02083204/26/2002
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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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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