Label: PREVAIL-FX ONE STEP- povidone-iodine and isopropyl alcohol solution

  • NDC Code(s): 57613-009-40
  • Packager: Productos Urologos de Mexico, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 21, 2016

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

  • ACTIVE INGREDIENT

    Isopropyl Alcohol 72.5% (w/w)

    Povidone-iodine USP 8.3% (0.83% available iodine)

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  • PURPOSE

    Antiseptic

    Antiseptic

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  • USES

    For preparation of the patient’s skin prior to surgery. Helps 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 risk of fire, PREP CAREFULLY:

    • solution contains alcohol and gives off flammable vapors.
    • 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).
    • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
    • Do not allow solution to pool.
    • Remove wet materials from prep area.
    • If prep accidentally drips into hair, allow to dry completely.

    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 iodine sensitive patients.
    • on open skin wounds or as a general skin cleanser.
    • in the eyes or for prepping mucous membranes.

    When using this product

    use in well ventilated area.

    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

    • to reduce the risk of fire the following strategies are recommended:
      • at the end of prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available.
      • use in a well ventilated area.
      • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
      • do not allow solution to pool.
      • tuck prep towels to absorb solution, and then remove.
      • remove wet materials from prep area.
      • drape after solution is completely dry.
    • Hold the bottle in an upright position.
    • Twist the applicator head in the direction of the arrow until it stops.
    • Firmly push the applicator head down into the bottle until a snap is heard.
    • Invert bottle and gently squeeze to dispense solution.
    • Once applicator sponge has been primed with solution, do not continue to squeeze the bottle
    • When applicable, press cotton-tipped swab securely against impregnated applicator head to wet, then clean umbilicus.
    • Apply thin, even coat to operative site. Do not blot.
    • If applying prep to a tight area (e.g., neck, skin folds), insert prep towels underneath to absorb excess solution.
    • Remove any excess prep with absorbent towels or gauze.
    • Discard prepping materials, including solution soaked materials.
    • Wait until prep is dry (3 minutes or more) on skin before draping or using ignition sources.
    • Remove with high pH-level soap and water.

    Other Information

    • Store at USP room temperature, 20-25°C (66-77°F)
    • Avoid excessive heat (not to exceed 104°F (40°C)

    Inactive Ingredients

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

    Questions?

    call: 1-800-523-0502 (M-F 8 AM-5PM CST)

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  • PRINCIPAL DISPLAY PANEL

    4VAIL-FX

    Cat. 4VAIL-FX

    NDC 57613-009-40

    Prevail-FX ® One Step Solution and Applicator

    Topical Patient Preoperative Skin Prep

    Non-sterile Solution

    Applicator is sterile if package is intact

    Povidone-iodine USP 8.3% (0.83% Available Iodine) with 72.5% Isopropyl Alcohol w/w 40ml

    For Single Use Only

    WARNING:

    FLAMMABLE, keep away from fire or flame.

    To reduce risk of fire, PREP CAREFULLY:

    • solution contains alcohol and gives off flammable vapors
    • 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).
    • avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
    • do not allow solution to pool.
    • remove wet material from prep area.

    See insert before using this product.

    1.4 fl oz

    U.S. Patent Nos. 6,228,354 and 7,201,525.

    51-10087

    Manufactured for CareFusion, Vernon Hills, IL 60061 USA

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  • INGREDIENTS AND APPEARANCE
    PREVAIL-FX ONE STEP 
    povidone-iodine and isopropyl alcohol solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57613-009
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 8.3 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 725 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57613-009-40 1 in 1 POUCH 06/01/1998
    1 40 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
    OTC monograph not final part333A 06/01/1998
    Labeler - Productos Urologos de Mexico, S.A. de C.V. (812552219)
    Registrant - CareFusion 2200. Inc. (832696038)
    Establishment
    Name Address ID/FEI Business Operations
    Productos Urologos de Mexico, S.A. de C.V. 812552219 label(57613-009) , pack(57613-009)
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