Label: PURPREP- povidone iodine and isopropyl alcohol sponge

  • NDC Code(s): 54365-014-41, 54365-014-42
  • Packager: CareFusion 213 LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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

  • ACTIVE INGREDIENT

    Isopropyl alcohol 72.5% w/w

    Povidone-iodine 8.3% w/w (0.83% available iodine)

  • PURPOSE

    Antiseptic

    Antiseptic

  • INDICATIONS & USAGE

    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.

    T o reduce risk of fire, PREP CAREFULLY:

    • do not use 26-mL applicator for head and neck surgery
    • 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 the solution to pool
    • remove wet materials from prep area
  • DO NOT USE

    Do not use

    • on children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption. Daily use of iodine on newborn infants may increase blood iodine level.
    • on open skin wounds or as a general skin cleanser
    • in the eyes or for prepping mucous membranes
    • on iodine sensitive patients
  • WHEN USING

    When using this product

    • use in well ventilated area.
    • use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn

  • STOP USE

    Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These maybe signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

      • use in a well ventilated area
      • do not allow solution to pool; tuck prep towels to absorb solution, and then remove
      • remove applicator from package; do not touch sponge
      • hold the applicator with the sponge down. Pinch wings 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 repeated back-and-forth strokes for 30 seconds
      • moist surgical sites (e.g., inguinal fold): use 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 prepping materials, including solution soaked materials. It is not necessary to use the entire amount available
  • OTHER SAFETY INFORMATION

    • store between 15-30 o C (59-86 o F)
    • avoid excessive heat above 40 o C (104 o F)
  • INACTIVE INGREDIENT

    Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water

  • QUESTIONS

    Questions? call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

  • PRINCIPAL DISPLAY PANEL

    7-960140 lidding

    7-960170_10.5mL

  • INGREDIENTS AND APPEARANCE
    PURPREP 
    povidone iodine and isopropyl alcohol sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL725 mg  in 1 mL
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE8.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54365-014-421 in 1 POUCH04/09/2020
    126 mL in 1 APPLICATOR; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NDC:54365-014-411 in 1 POUCH05/21/2020
    210.5 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
    OTC Monograph Drug505G(a)(3)04/09/2020
    Labeler - CareFusion 213 LLC (826496312)
    Registrant - Becton, Dickinson and Company (832696038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Becton, Dickinson and Company124987988manufacture(54365-014)
    Establishment
    NameAddressID/FEIBusiness Operations
    CareFusion 213 LLC826496312manufacture(54365-014) , pack(54365-014) , label(54365-014) , sterilize(54365-014) , analysis(54365-014)