Urea Information
Urea ()
Urea () Description
Urea () Lotion 35% is a keratolytic emollient which is a gentle, yet potent, tissue softener for skin.
Each gram of Urea () Lotion 35% contains 35% Urea () and the following inactive ingredients: caprylic/capric triglyceride, carbomer, cetyl alcohol, cholesterol, disodium EDTA, glycosphingolipids, hydrogenated polydecence, hydroxyethylcellulose, lactic acid, linoleic acid, phospholipids, polysorbate 60, PPG-5 laureth-5, purified water, sodium polyacrylate, sorbitan stearate, triethanolamine, vitamin E, xanthan gum and zinc pyrithione.
Urea () is a diamide of carbonic acid with the following chemical structure:
Urea () Clinical Pharmacology
Urea () gently dissolves the intercellular matrix which results in loosening the shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.
Urea () Indications And Uses
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous pr purulent debris or eschar. Urea () is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, prurutus, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis Palmaris, keratoderma, corns and calluses.
Urea () Contraindications
Known hypersensitivity to any of the listed ingredients.
Urea () Warnings
For external use only. Avoid contact with eyes, lips or mucous membranes.
Urea () Precautions
This mediation 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:
NURSING MOTHERS:
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Urea () Adverse Reactions
Transmit stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Urea () Dosage And Administration
Apply Urea () Lotion 35% to affected skin twice per day, or as directed by physician. Rub in until lotion is completely absorbed.
Urea () How Supplied
Urea () Lotion 35% is supplied as a:
7 oz (207 mL) bottle, NDC 0168-0488-07
11 oz (325 mL) bottle, NDC 0168-0488-11
Store at 15°-30° C (59°-86° F).
Protect from freezing.
Manufactured for: E. FOUGERA & CO.A division of Nycomed US Inc.Melville, New York 11747
Manufactured by: Pegasus LaboratoriesPensacola. FL 32514
IL278A
R12/08
Urea ()
Urea () Package Label – Principal Display Panel – Oz Bottle Label
NDC 0168-0488-07
Fougera
Urea () LOTION35%
In a vehicle containingVitamin E, Lactic Acid and Zinc
For Topical Use Only
Rx only
Net Wt. 7 oz (207 mL)
E. FOUGERA & CO.A division of Nycomed US Inc.Melville, New York 11747
Urea () Package Label – Principal Display Panel – Oz Carton
NDC 0168-0488-07
Fougera
Urea () LOTION35%
In a vehicle containingVitamin E, Lactic Acid and Zinc
For Topical Use Only
Rx only
NET WT. 7 oz
(207 mL)
E. FOUGERA & CO.A division of Nycomed US Inc.Melville, New York 11747
Urea () Package Label – Principal Display Panel – Oz Bottle Label
NDC 0168-0488-11
Fougera
Urea () LOTION35%
In a vehicle containingVitamin E, Lactic Acid and Zinc
For Topical Use Only
Rx only
Net Wt. 11 oz (325 mL)
E. FOUGERA & CO.A division of Nycomed US Inc.Melville, New York 11747
Urea () Package Label – Principal Display Panel – Oz Carton
NDC 0168-0488-11
Fougera
Urea () LOTION35%
In a vehicle containingVitamin E, Lactic Acid and Zinc
For Topical Use Only
Rx only
NET WT. 11 oz
(325 mL)
E. FOUGERA & CO.A division of Nycomed US Inc.Melville, New York 11747
