Label: GOOD CARE POVIDONE IODINE - povidone-iodine swab

  • NDC Code(s): 50685-001-01, 50685-001-03
  • 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 23, 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
    • First aid antiseptic to help prevent the risk of skin 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 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 longer than 1 week unless directed by a doctor
    Discontinue use if irritation and redness develop.
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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.

    For use as a first aid antiseptic clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

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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

    citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide

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  • SPL UNCLASSIFIED SECTION

    Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

    3-91 Jiulicun Yongzheng Street Jinzhou District Dalian China 116100

    Tel: +86-411-87857288

    Made in China      www.dl-goodwood.com

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  • PRINCIPAL DISPLAY PANEL

    Good Care

    Povidone Iodine, USP Swabsticks

    Antiseptic    Germicide

    • Topical pre-surgical and first aid antiseptic swabstick
    • For hospital and professional use only
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  • INGREDIENTS AND APPEARANCE
    GOOD CARE POVIDONE IODINE 
    povidone-iodine swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50685-001
    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 mL  in 100 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:50685-001-01 2 mL in 1 POUCH
    2 NDC:50685-001-03 5.5 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 10/01/2010
    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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