Label: CHLORAPREP SWABSTICK- chlorhexidine gluconate and isopropyl alcohol solution

  • NDC Code(s): 54365-401-28, 54365-401-29
  • Packager: CareFusion 213 LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 23, 2024

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

  • Active ingredients

    Chlorhexidine gluconate (CHG), 2% w/v

    and Isopropyl alcohol (IPA), 70% v/v

  • Purpose

    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.

    • do not use with electrocautery procedures

    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.
    • maximal treatment area using
    • one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm 2)
    • 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 repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, 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 repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, 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.
  • Other information

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

    • 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

    54365-401-28

    PRINCIPAL DISPLAY PANEL-CARTON

    BD ChloraPrep™ Single Swabstick

    Chlorhexidine gluconate (CHG), 2% w/v

    and Isopropyl alcohol (IPA), 70% v/v Swab

    Patient Preoperative Skin Preparation

    Sterile Solution

    Applicator is sterile if package is intact

    1.75 mL Applicators

    NDC 054365-401-28

    Ref 930100

    54365-401-29

    PRINCIPAL DISPLAY PANEL-CARTON

    BD ChloraPrep™ Triple Swabstick

    Chlorhexidine gluconate (CHG), 2% w/v

    and Isopropyl alcohol (IPA), 70% v/v Swab

    Patient Preoperative Skin Preparation

    Sterile Solution

    Applicator is sterile if package is intact

    5.25 mL Applicators

    NDC 054365-401-29

    Ref 930103

  • INGREDIENTS AND APPEARANCE
    CHLORAPREP SWABSTICK 
    chlorhexidine gluconate and isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-401
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54365-401-2848 in 1 CARTON05/13/2024
    11 in 1 POUCH
    11.75 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:54365-401-2940 in 1 CARTON05/13/2024
    23 in 1 POUCH
    25.25 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02155505/13/2024
    Labeler - CareFusion 213 LLC (826496312)
    Registrant - Becton, Dickinson and Company (832696038)
    Establishment
    NameAddressID/FEIBusiness Operations
    CareFusion 213 LLC826496312manufacture(54365-401) , analysis(54365-401) , label(54365-401) , pack(54365-401) , sterilize(54365-401)