FDA Label for Urea
View Indications, Usage & Precautions
Urea Product Label
The following document was submitted to the FDA by the labeler of this product Exact-rx, 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.
Other
(in a cream base)
Rx only
For external use only. Not for ophthalmic use.
Keep away from eyes, lips and mucous membranes.
Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
00-0200-99-205-01
Iss:10/11
Description
DESCRIPTION: UREA CREAM 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 45% Urea in a cream base of: camphor, edetate disodium, alcohol, eucalyptus oil, hydroxyethyl cellulose, menthol, purified water, titanium dioxide, sodium hydroxide.
CHEMISTRY: Urea is a diamide of carbonic acid with the following chemical structure:
Clinical Pharmacology
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 removal of devitalized nail plate tissue.
Pharmacokinetics
PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known.
Indications & Usage
INDICATIONS AND USES: Urea 45% Cream is indicated for use in the topical treatment 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
CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.
Warnings
WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes. If swallowed seek medical attention or contact a Poison Control Centter immediately.
Precautions
PRECAUTIONS: Use this medication only as directed by a physician. It should not be used to treat and condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.
Pregnancy
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, Urea Cream 45% should be given to a pregnant woman only if clearly needed.
Nursing Mothers
NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea Cream 45% is administered to a nursing woman.
Adverse Reactions
ADVERSE REACTIONS: Transient stinging, burning itching or irritation may occur and normally disappear on discontinuing medication.
Call your doctor for medical advice about side effects.
Dosage & Administration
DOSAGE AND ADMINSTRATION: Apply Urea Cream 45% to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.
How Supplied
HOW SUPPLIED: Urea Cream 45% is supplied in 9 oz. (255 g) tubes, NDC 42808-0202-09.
Storage And Handling
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). See USP Controlled Room Temperature. Protect from freezing.
Principal Display Panel
For External Use Only
NDC 42808-0202-09 Rx Only
Urea
In a vehicle containing
camphor, eucalyptus oil
and menthol
45%
CREAM
Exact-Rx.
INCORPORATED
Net Wt. 9 oz (255 g)
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