Label: POVIDONE IODINE- povidone-iodine solution

  • NDC Code(s): 0603-1550-56, 0603-1550-58
  • Packager: Qualitest Pharmaceuticals
  • 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 11/12

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

  • Active ingredient

    Povidone-iodine, 10%

    (1% available iodine)

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  • Purpose

    First aid antiseptic

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  • Uses

    first aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
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  • Warnings
  • For external use only
  • Do not use

    • in the eyes
    • over large areas of the body
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  • ASK DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

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  • Stop use and ask a doctor if

    • the condition persists or gets worse
    • you need to use this product for more than 1 week
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  • 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 the affected area
    • apply a small amount of product to the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
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  • Other information

    • store at 15° to 30°C (59° to 86°F)

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

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  • Inactive ingredients

    citric acid, dibasic sodium phosphate, glycerin, purified water

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    QUALITEST PHARMACEUTICALS
    HUNTSVILLE, AL 35811

    Rev. 2/10 R6
    8071710  1550

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-1550
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) POVIDONE-IODINE 100 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    SODIUM PHOSPHATE, DIBASIC  
    GLYCERIN  
    WATER  
    Product Characteristics
    Color BROWN (dark brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-1550-56 237 mL in 1 BOTTLE, PLASTIC
    2 NDC:0603-1550-58 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333A 04/01/1995
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE(0603-1550)
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