Label: GORDONS UREA 40 - urea ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 16, 2010

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  • DESCRIPTION

    Urea 40% has been used for many years for the nonsurgical avulsion of mycotic nails. Nonsurgical avulsion is a conservative procedure which can be utilized by the geriatric, diabetic or vascular patient. Nonsurgical avulsion has the advantage of avoiding the possible side effects of oral drugs.


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  • HOW SUPPLIED

    Gordon's Urea 40% is supplied as 1 oz. Jars.

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  • SPL UNCLASSIFIED SECTION

    Urea 40%, Petrolatum 17.8%, White Wax 5%, Anhydrous Lanolin 15%, Purified Water

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  • INDICATIONS & USAGE

    For loosening, debriding and avulsion of devitalized nail tissue. Apply to affected area in an apertured pad. Protect surrounding skin. Apply Urea 40% to the diseased nail surface and cover with plastic film. Anchor with adhesive tape. Cover with "finger cut" of plastic or vinyl glove and anchor with more adhesive tape. Keep dry and occlusive for 3-7 days. Cleanse, debride and reapply if necessary.


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  • WARNINGS AND PRECAUTIONS

    Hypersensitivity to Urea or any of the components of this preparation. If redness or irritation occurs, discontinue use. For external use only. Keep out of reach of children.

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  • SPL UNCLASSIFIED SECTION

    Urea is an organic compound present in mammals. Wehn it was first synthesized from an inorganic compound in the last century. Urea is now prepared by heating Calcium Cyanamide with water under pressure. Proteolytic action on the nail plate and nail bed by its keratolytic properties, with the resulting maceration inducing an effective, painless and bloodless nail removal procedure.

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  • INGREDIENTS AND APPEARANCE
    GORDONS UREA 40  
    urea ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10481-3005
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea 0.4 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10481-3005-1 30 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/16/2010
    Labeler - Gordon Laboratories (002333847)
    Registrant - Gordon Laboratories (002333847)
    Establishment
    Name Address ID/FEI Business Operations
    Gordon Laboratories 002333847 manufacture
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