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

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

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

  • 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 or injection: Helps to reduce bacterial that potentially can cause skin infection.

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  • Warnings

    For external use only. 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 all wet materials from prep area

    Do not use

    on patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
    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.

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  • Directions

    use with care in premature infants and infants under 2 months of age. These products may cause irritation and chemical burns.
    use in a well ventilated area
    maximal treatment area for one applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
    tear pouch at side notch to reveal applicator handle. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
    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
    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 ºC (59-86 °F)
    avoid freezing and excessive heat above 40 ºC (104 °F)
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  • Inactive ingredients

    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

     

    Carton Primary Display Panel

    Single Swabstick Carton

    NDC 054365-400-07

    1.75ml SINGLE SWABSTICK APPLICATORS

    Clear

    Single Use

    Latex Free

    48 applicators

    0.06 fl. oz. (1.75 ml) each

    ChloraPrep® One-Step

    2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)

    Patient Preoperative Skin Preparation

    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 material from prep area

    Store between 15-30 ºC (59-86 ºF)

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

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  • INGREDIENTS AND APPEARANCE
    CHLORAPREP ONE-STEP 
    chlorhexidine gluconate and isopropyl alcohol solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54365-400
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 20 mg  in 1 mL
    ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54365-400-07 48 in 1 CARTON
    1 1 in 1 POUCH
    1 1.75 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA021555 05/10/2005
    Labeler - CareFusion 213 LLC (826496312)
    Registrant - CareFusion 213 LLC (831684456)
    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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