Label: GOOD CARE POVIDONE IODINE PAD - povidone-iodine swab

  • NDC Code(s): 50685-007-01
  • Packager: Dalian Goodwood Medical Care Ltd.
  • 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 March 28, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient

    Povidone Iodine USP, 10% w/v

    (equivalent to 1% titratable iodine)

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  • PURPOSE

    Purpose

    Antiseptic

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  • INDICATIONS & USAGE

    Uses

    • Health-care antiseptic for preparation of the skin prior to surgery
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  • WARNINGS

    Warnings

    For external use only.

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  • DO NOT USE

    Do not use or apply in the eyes
    • on individuals who are allergic or sensitive to iodine
    • over large areas of the body
    • as a first aid antiseptic
    • animal bites
    • serious burns
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  • STOP USE

    Stop use and consult a doctor if the condition persists or gets worse.

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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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  • DOSAGE & ADMINISTRATION

    Directions

    For preparation of the skin prior to surgery clean the affected area, remove swab by the stick, apply to the operative site prior to surgery.


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  • STORAGE AND HANDLING

    Other information

    Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

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  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified water

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  • SPL UNCLASSIFIED SECTION

    Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

    Made in China      www.dl-goodwood.com

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  • PRINCIPAL DISPLAY PANEL

    Good Care

    Povidone Iodine pad
    10% povidone iodine

    For Disinfection Use
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  • INGREDIENTS AND APPEARANCE
    GOOD CARE POVIDONE IODINE PAD 
    povidone-iodine swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50685-007
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50685-007-01 0.4 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/23/2011
    Labeler - Dalian Goodwood Medical Care Ltd. (529575699)
    Registrant - Dalian Goodwood Medical Care Ltd. (529575699)
    Establishment
    Name Address ID/FEI Business Operations
    Dalian Goodwood Medical Care Ltd. 529575699 manufacture
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