Label: DECOLORIZED IODINE- alcohol liquid 

  • Label RSS
  • 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 02/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Ethyl Alcohol 48%

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  • Purpose

    First Aid Antiseptic                        

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  • Use

    first aid to help prevent infection in minor cuts, scrapes and burns.

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  • Warnings

    For external use only

    Flammable, keep away from fire or flame

    When using this product 

    do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    Stop use and consult doctor if the

    condition persists or gets worse. Do not use this product for longer than 1 week unless directed by a doctor.

    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 on the area 1 to 3 times daily.
    • may be covered with sterile bandage.
    • if bandaged, let dry first.
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  • Other information 

    store at room temperature

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  • Inactive ingredients

    ammonium hydroxide, iodine, potassium iodide, and purified water

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  • PRINCIPAL DISPLAY PANEL

    NDC 37205-648-16
    Leader®
    Decolorized Iodine
    Alcohol 48%
    FIRST AID ANTISEPTIC
    For External Use Only
    2 FL OZ (59 mL)

    NDC 37205-648-16
Leader®
Decolorized Iodine
Alcohol 48%
FIRST AID ANTISEPTIC
For External Use Only
2 FL OZ (59 mL)

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  • INGREDIENTS AND APPEARANCE
    DECOLORIZED IODINE 
    ethyl alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-648
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 0.45 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    AMMONIA  
    IODINE  
    POTASSIUM IODIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-648-16 59 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333A 01/01/1979
    Labeler - Cardinal Health (097537435)
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