FDA Label for Cem-urea
View Indications, Usage & Precautions
Cem-urea Product Label
The following document was submitted to the FDA by the labeler of this product Prugen, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
CEM-UreaTM (45% Urea) is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of CEM-UreaTM (45% Urea) contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, methyl paraben, propylene glycol and purified water.Urea is a diamide of carbonic acid with the following chemical structure:
Clinical Pharmacology
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.
Pharmacokinetics
The mechanism of action of topically applied Urea is not yet known.
Indications & Usage
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails.
Contraindications
Known hypersensitivity to any of the listed ingredients.
Warnings And Precautions
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
Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies
in pregnant women. Because animal reproductive studies are not always predictive of human response, CEM-UreaTM (45% Urea) should be given to a pregnant woman only if clearly needed.
Nursing Mothers
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 CEM-UreaTM (45% Urea) is administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Adverse Reactions
Transient stinging, burning, itching or irritation may occur and normally disappear
on discontinuing the medication.
Dosage & Administration
DIRECTIONS FOR NAILS: Apply CEM-UreaTM (45% Urea) to diseased or damaged nail tissue twice per day, or as directed by a physician.
DIRECTIONS FOR SKIN: Apply CEM-UreaTM (45% Urea) to affected area(s) twice per day, or as directed by a physician.
How Supplied
CEM-UreaTM (45% Urea) 20 mL tube, NDC 42546-100-20
Storage And Handling
Store at controlled room temperature 15°-30° C (59°-86° F).
Protect from freezing.
Package Label.Principal Display Panel
NDC 42546-100-20
CEM-Urea Pre-Filled Applicator 45% urea
In a vehicle containing Menthol, Camphor, and Eucalyptus Oil
Rx only
0.68 FL OZ (20 mL)
PruGen, Inc. Pharmaceuticals
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