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 04/15

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 bacteria that potentially can cause skin infection.

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  • Warnings

    For external use only. Flammable, keep away from fire or flame.

    • do not use with electrocautery procedures

    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 or infants under 2 months of age. These products may cause irritation or chemical burns.
    • maximal treatment area using three swabsticks sequentially is approximately 5 in. x 5 in. (160 cm 2)
    • tear pouch at side notch to reveal applicator handles. 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 (use each swabstick sequentially within the 30 seconds). Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
    • moist surgical sites (e.g., inguinal fold): use gentle repeated back-and-forth strokes for 2 minutes (use each swabstick sequentially within the 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.
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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 Front Panel

    NDC 054365-400-08

    5.25ml TRIPLE SWABSTICK APPLICATORS

    Clear

    Do Not Reuse

    Not made with natural rubber latex

    40 packages

    0.18 fl. oz. (5.25 ml) each

    ChloraPrep ®

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

    Patient Preoperative Skin Preparation

    Non-Sterile Solution

    Applicator is non-sterile

    Professional Use Only

    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 Item Code (Source) NDC:54365-400
    Route of Administration TOPICAL DEA Schedule     
    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 .7 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54365-400-08 40 in 1 CARTON
    1 3 in 1 POUCH
    1 1.75 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 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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