Package insert / prescribing information
Generic name: urea
Dosage form: cream
Drug class: Topical emollients
Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.
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.
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Pro-39 Urea (Urea 39% Cream) Rx only
For Topical Dermatological Use Only
Rx Only - Caution: Federal Law restricts this product to sale by, or on the order of a licensed healthcare practitioner.
Pro-39 Urea Description
Pro-39 Urea Cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.
Each gram of Pro-39 Urea Cream contains:
ACTIVE: 39% Urea in a cream base of:
INACTIVES: Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Propylene Glycol, Dimethicone, Melaleuca Alternifolia (Tea Tree) Oil, Helianthus Annuus (Sunflower) Oil, Chamomilla Recutita (Chamomile) Extract, Carbomer, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin.
Urea is a diamide of carbonic acid with the following chemical structure:
Pro-39 Urea - 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.
The mechanism of action of topically applied Urea is not yet known.
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 or prurient 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, ingrown and devitalized nails.
Pro-39 Urea Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients.
For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin.
Stop use and ask a doctor if redness or irritation develops. After applying this medication, wash hands and unaffected areas thoroughly. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
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 reproduction studies are not always predictive of human response, Pro-39 Urea Cream 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 Pro-39 Urea Cream is administered to a nursing woman.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Pro-39 Urea - Dosage and Administration
Apply Pro-39 Urea Cream to affected skin two to three times per day as needed or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue two to three times per day or as directed by a physician. Best applied to affected areas immediately after showering and just before bedtime.
How is Pro-39 Urea Supplied
Pro-39 Urea (39% Urea Cream) is supplied in:
8oz (227gm) Jar NDC 72678-034-01
Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). Protect from freezing. [See USP Controlled Room Temperature.]
Lifsa Drugs LLC, New Brunswick, NJ 08901
PRINCIPAL DISPLAY PANEL - 227 gm Jar Label
Pro-39 Urea UREA 39% CREAM
Smooth, Spreadable, Moisturizing
Pro-39’s high amount of urea exhibits intensive keratolyic and peeling effects. Thoroughly nourishes, helping to prevent cracks, and drying of your skin.
FOR TOPICAL USE ONLY
Net WT. 8OZ (227 gm)
|Labeler - Lifsa Drugs Llc (081205160)|
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