Label: PREP SOLUTION - povidone-iodine solution 

  • Label RSS
  • NDC Code(s): 65517-0009-1, 65517-0009-2, 65517-0009-3, 65517-0009-4, view more
    65517-0009-5, 65517-0009-6
  • Packager: Dukal Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 07/10

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

  • PRINCIPAL DISPLAY PANEL

    MediChoice

    Prep Solution

    Topical Antiseptic

    Povidone Iodine USP

    10% Topical Solution

    Distributed by Owens and Minor

    Mechanicsville, VA 23116

    (804) 723-7000

    owens-minor.com


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  • ACTIVE INGREDIENT

    Active Ingredient

    Povidone-Iodine 10% (equivalent to 1% available iodine)

    Purpose

    Antiseptic

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  • PURPOSE

    Uses

    Healthcare antiseptic for preparation of skin prior to surgery.

    First Aid Antiseptic to help prevent infection in minor cuts scrapes and burns.

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  • WARNINGS

    Warnings

    For external use only.

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  • DO NOT USE

    Do Not Use

    In the eyes.

    longer than 1 week unless directed by a doctor

    on individuals who are allergic or sensitive to iodine

    or apply over large area of the body

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  • STOP USE

    Stop use and ask a doctor

    If irritation and redness develop

    If condition persists more than 72 hours

    In case of deep or puncture wounds, animal bites or serious burns, consult a doctor

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    Directions

    Clean the affected area

    For preparation of skin prior to surgery:

    apply the product to the operative site prior to surgery.

    For first aid antiseptic:

    apply a small amount of this product on the area 1 to 3 times daily.

    May be covered with a sterile bandage.

    If bandaged, let dry first.

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  • STORAGE AND HANDLING

    Other information

    Protect from freezing

    Avoid excessive heat

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Citric Acid, Disodium Phosphate, Glycerin, Polysorbate 80, Sodium Citrate, Water

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  • PVP Prep Label
  • INGREDIENTS AND APPEARANCE
    PREP SOLUTION 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65517-0009
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (POVIDONE and IODINE) POVIDONE-IODINE 1.20 mL  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65517-0009-1 59 mL in 1 BOTTLE
    2 NDC:65517-0009-2 59 mL in 1 BOTTLE, SPRAY
    3 NDC:65517-0009-3 118 mL in 1 BOTTLE
    4 NDC:65517-0009-4 237 mL in 1 BOTTLE
    5 NDC:65517-0009-5 473 mL in 1 BOTTLE
    6 NDC:65517-0009-6 946 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333 01/01/2010
    Labeler - Dukal Corporation (791014871)
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