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 June 12, 2019

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

  • WARNING. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

    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 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 the 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 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 with known allergies 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 8.4 in. x 8.4 in. (457 cm 2)
    • 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 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 °C (59-86 °F)
    • avoid freezing and excessive heat above 40 °C (104 °F)
  • Inactive ingredients

    FD&C yellow #6 dye, 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

    ChloraPrep 10.5 mL Hi-Lite Orange

    PRINCIPAL DISPLAY PANEL-CARTON

    10.5 ml

    APPLICATORS

    Hi-Lite Orange ®

    Not made with natural rubber latex

    STERILE EO

    Professional Use Only

    Store between 15-30 °C (59-86 °F)

    Avoid freezing and excessive heat

    above 40 °C (104 °F)

    25 applicators

    0.36 fl. oz. (10.5 ml) each

    NDC 054365-400-12

    Cat. No. 260715

    ChloraPrep ® with Tint

    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

    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 materials from prep area
  • 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
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54365-400-1225 in 1 CARTON08/18/2006
    11 in 1 POUCH
    110.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02083208/18/2006
    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)