Label: CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution

  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 22, 2021

If you are a consumer or patient please visit this version.

  • Active ingredients

    Chlorhexidine gluconate 2% w/v

    Isopropyl alcohol 70% v/v

  • Purposes



  • 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 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 for one applicator is approximately 2.5 in. x 2.5 in. (42 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 of the sponge for approximately 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 approximately 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 oF)

    • avoid freezing and excessive heat above 40 oC (104 oF)

  • Inactive Ingredient

    USP purified water

  • Questions? • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

  • Prinicipal Display Panel-Carton


    Principal Display Panel-Carton

    BD ChloraPrep FREPP Clear

    1.5 mL Applicators

    2% w/v chlorhexidine gluconate (CHG)

    and 70 % v/v isopropyl alcohol (IPA)

    Patient Preoperative Skin Preparation

    Sterile Solution

    Applicator is sterile if package is intact

    Store between 15-30 oC (59-86 oF)

    Avoid freezing and excessive heat above 40 oC (104 oF)

    0.05 fl.oz (1.5 mL) each

    20 Applicators


    NDC 54365-400-30

    REF 930299

    Not made with natural rubber latex

    Do not reuse

    Sterile EO


    External Use Only

    Professional Use Only

    CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co. Made in the USA of US and imported parts

    chlorhexidine gluconate and isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54365-400-3020 in 1 CARTON05/24/2019
    11 in 1 POUCH
    11.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - CareFusion 213, LLC (826496312)
    Registrant - CareFusion 2200, Inc (832696038)
    NameAddressID/FEIBusiness Operations
    CareFusion 213, LLC826496312analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400)