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

  • NDC Code(s): 50685-009-01, 50685-009-02, 50685-009-03
  • Packager: Dalian Goodwood Medical Care Ltd.
  • 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 02/13

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  • Good Care Povidone Iodine, USP Swabsticks
  • Active Ingredient

    Povidone Iodine USP, 10%

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  • Purpose

    Antiseptic

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  • 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

    • For external use only. 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.

    Consult a doctor in case of deep or puncture wounds, animal bites, serious burns.

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

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control right away
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  • Directions

    For preparation of the skin prior to surgery clean the affected area, remove swab by 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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  • Other Information

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

    Purified water, Povidone Iodine, Citric Acid Disodium Hydrogen Phosphate Dodecahydrate Potassium Iodate Nonoxynol

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  • Manufactured by Dalian Goodwood Medical Care Ltd.

    Made in China

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  • Good Care Povidone Iodine, USP Swabsticks (1s) (50 pouches/box) (50685-009-01)
  • Good Care Povidone Iodine, USP Swabsticks (2s) (25 pouches/box) (50685-009-02)
  • Good Care Povidone Iodine, USP Swabsticks (3s) (25 pouches/box) (50685-009-03)
  • INGREDIENTS AND APPEARANCE
    GOOD CARE POVIDONE IODINE SWABSTICKS  
    povidone-iodine swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50685-009
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) IODINE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CITRIC ACID MONOHYDRATE  
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE  
    POTASSIUM IODATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50685-009-01 50 in 1 BOX
    1 0.7 g in 1 PACKET
    2 NDC:50685-009-02 25 in 1 BOX
    2 1.4 g in 1 PACKET
    3 NDC:50685-009-03 25 in 1 BOX
    3 2.1 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 02/13/2013
    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(50685-009)
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