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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated May 24, 2019

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

  • WARNING FLAMMABLE

    Keep away from fire or flame.

    To reduce the risk of fire, PREP CAREFULLY:

    • do not use 26-mL applicator for head and neck surgery or on an area

    smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.

    • 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
  • 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.

    To reduce risk of fire, PREP CAREFULLY:

    • do not use 26-ml applicator for head and neck surgery
    • do not use on an area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.
    • 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
  • 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 • use in a well ventilated

    area • maximal treatment area for one applicator is approximately

    13.2 in. x 13.2 in. (1126 cm2). Do not use 26-ml applicator for area smaller than

    8.4 in. x 8.4 in. Use a smaller applicator instead. • do not use 26-ml applicator

    for head and neck surgery • remove applicator from package; do not touch

    sponge • hold the applicator with the sponge down. Pinch wing only once to

    activate the ampules 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 • 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 Ingredients

    USP purified water

  • Questions?

    www.chloraprep.com • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

  • Package Label

    54365-400-37

    Package Label-

    BD ChloraPrep Clear

    26 mL Applicator

    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

    Clear

    REF 930800

    NDC 54365-400-37

    External Use Only

    Professional Use Only

    STERILE EO

    STERILE SOLUTION

    CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co.

    Made in the USA of US and imported parts www.bd.com

  • INGREDIENTS AND APPEARANCE
    CHLORAPREP ONE-STEP 
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54365-400-371 in 1 POUCH05/24/2019
    126 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02083205/24/2019
    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)