Label: SCRUB CARE POVIDONE IODINE TOPICAL PAINT- providone 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

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 12, 2016

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  • Active ingredient

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

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  • Purpose

    Antiseptic

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  • Uses

    • for preparation of skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
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  • Warnings

    For external use only

    Do not use

    • in the eyes
    • on persons allergic to iodine

    Stop use and ask a doctor if

    • Skin shows symptoms of irritation, sensitivity, redness, pain or swelling. If condition persists more than 72 hours, consult a doctor.
    • 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

    • clean area
    • apply solution to surgical site following povidone iodine scrub application
    • starting at the surgical site moving outward in concentric circles
    • allow a minimum of 2 minutes drying time before draping
    • 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?

    Call: 1-800-523-0502 Mon.-Fri. 8 AM-5 PM CST

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  • Package/Label Principal Display Panel

    Cat. 29906-004

    NDC 50425-011-98

    Cat. 29906-004

    Scrub Care® 10%

    Povidone-iodine, Paint

    Antiseptic

    Non-sterile Solution

    10% Povidone-iodine, USP

    For preparation of skin prior to surgery.

    Helps reduce bacteria that potentially

    can cause skin infection.

    For Single Use Only

    Manufactured for

    CareFusion

    Vernon Hills, IL 60061 USA

    51-10114

    Net Contents: 4 fl. oz. (118 ml)

    CareFusion

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  • INGREDIENTS AND APPEARANCE
    SCRUB CARE POVIDONE IODINE TOPICAL PAINT 
    providone iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50425-011
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50425-011-59 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2001
    2 NDC:50425-011-98 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2001
    3 NDC:50425-011-97 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2001
    4 NDC:50425-011-96 472 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2001
    5 NDC:50425-011-95 944 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2001
    6 NDC:50425-011-94 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2001
    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 2200 Inc (832696038)
    Establishment
    Name Address ID/FEI Business Operations
    Thatcher Company 041307356 manufacture(50425-011)
    Establishment
    Name Address ID/FEI Business Operations
    CareFusion 213 LLC 826496312 pack(50425-011)
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