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 September 27, 2017

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:

    • do not use 26-ml applicator for head and neck surgery or on an area smaller than 8.4 in. × 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
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  • 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
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  • Active ingredients

    Chlorhexidine gluconate 2% w/v

    Isopropyl alcohol 70% v/v

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  • Purposes

    Antiseptic

    Antiseptic

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  • Use

    for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

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  • Warnings

    For external use only. 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
    • 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.

    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.

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  • 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.

    • remove applicator from package; do not touch sponge
    • hold 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.

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  • Other information

    • store between 15-30 °C (59-86 °F)
    • avoid freezing and excessive heat above 40 °C (104 °F)
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  • Inactive ingredients

    FD&C yellow #6 dye, USP purified water

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  • Questions?

    • www.chloraprep.com
    • call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)
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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CHLORAPREP ONE-STEP 
    chlorhexidine gluconate and isopropyl alcohol solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54365-400
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 20 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54365-400-13 1 in 1 POUCH 08/18/2006
    1 26 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020832 08/18/2006
    Labeler - CareFusion 213 LLC (826496312)
    Registrant - CareFusion 2200, Inc (832696038)
    Establishment
    Name Address ID/FEI Business Operations
    CareFusion 213 LLC 826496312 analysis(54365-400) , manufacture(54365-400) , label(54365-400) , pack(54365-400)
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