Label: SCRUB CARE POVIDONE IODINE TOPICAL PAINT- povidone-iodine solution

  • NDC Code(s): 50425-011-59, 50425-011-94, 50425-011-95, 50425-011-96, view more
    50425-011-97, 50425-011-98
  • Packager: CareFusion 213 LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 08/12

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

  • Active ingredient

    Povidone-Iodine, USP 10% (1.0% available iodine)

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  • Purpose

    Antiseptic

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  • Uses

    Prepping intact skin and mucous membranes prior to surgery
    Helps reduce bacteria that potentially can cause skin infection
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  • Warnings

    For external use only
    Avoid use on persons allergic to iodine
    Do not use in the eyes
    Discontinue use if irritation and redness develop. If condition persist for more than 72 hours consult a doctor.

    Stop use and ask a doctor if

    Skin shows symptoms of irritation, sensitivity, redness, pain or swelling
    In case of deep puncture wounds or serious burns

    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 full strength
    Apply solution to operative site following povidone iodine scrub application
    Using a circular motion, start at incision site and move outward
    Remove all soiled underdrapes
    Do not allow solution to pool
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  • Other information

    Store at room temperature
    Avoid excessive heat (above 104°F/40°C)
    Protect from freezing
    Latex Free
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  • Inactive ingredients

    Citric Acid, Glycerol, Nonylphenol Ethoxylate, Purified Water, Sodium Hydroxide

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  • Questions?

    Report serious side effects, call: 1-800-523-0502 Mon.-Fri. 8 AM-5 PM CST

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  • Package/Label Principal Display Panel

    PVPI Paint Prinicipal Label

    Scrub Care 1 gal PVPI Paint Label

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  • INGREDIENTS AND APPEARANCE
    SCRUB CARE POVIDONE IODINE TOPICAL PAINT 
    providone iodine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50425-011
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) IODINE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    WATER  
    SODIUM HYDROXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50425-011-59 59 mL in 1 BOTTLE
    2 NDC:50425-011-98 118 mL in 1 BOTTLE
    3 NDC:50425-011-97 236 mL in 1 BOTTLE
    4 NDC:50425-011-96 472 mL in 1 BOTTLE
    5 NDC:50425-011-95 944 mL in 1 BOTTLE
    6 NDC:50425-011-94 3785 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/01/2001
    Labeler - CareFusion 213 LLC (831684456)
    Registrant - CareFusion 213 LLC (831684456)
    Establishment
    Name Address ID/FEI Business Operations
    Thatcher Company 041307356 MANUFACTURE(50425-011)
    Establishment
    Name Address ID/FEI Business Operations
    Productos Urologos de Mexico, S.A. de C.V 812552219 LABEL(50425-011), PACK(50425-011)
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