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Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.
The mechanism of action of topically applied Urea is not yet known.
Known hypersensitivity to any of the listed ingredients.
For external use only. Avoid contact with eyes, lips or mucous membranes.
This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.
Pregnancy Category C. Animal reproduction studies have not been conducted with Urea 40 Gel/Lotion. It is also now known whether Urea 40 Gel/Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urea 40 Gel/Lotion should be given to a pregnant woman only if clearly needed.
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea 40 Gel/Lotion is administered to a nursing woman. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Apply Urea 40 Gel/Lotion to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day, or as directed by a physician.
Urea 40 Gel or Lotion supplied as a:Gel: 15 mL (1/2 oz.) bottle, NDC 49769-101-15Lotion: 8 oz. bottle, NDC 49769-101-08 Store at controlled room temperature 15°-30°C (59°-86°F).Protect from freezing. Manufactured for: Kylemore Pharmaceuticals Port St. Joe, FL 32456101-10 Rev. 12/09
Urea 40 Gel Carton:
Urea 40 Gel Label:
Kylemore Pharmaceuticals, LLC
Rx Only 45% Urea Lotion
GORDONS UREA 40
Rx Only 45% Urea Nail Gel In a vehicle containing Camphor, Eucalyptus Oil and Menthol )
CEM-UREA TM PRE-FILLED APPLICTOR REV.1.0
Urea Cream, 40% Urea Lotion, 40% Urea Gel, 40%
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