Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Urea Cream 45% is supplied in 9 oz. (255 g) tubes, NDC 42808-0202-09.; PRINCIPAL DISPLAY PANEL Urea cream Urea Insert
- HOW SUPPLIED: Urea Cream 45% is supplied in 9 oz. (255 g) tubes, NDC 42808-0202-09.
- PRINCIPAL DISPLAY PANEL Urea cream Urea Insert
Overview
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: structure
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.
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.
Warnings & Precautions
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.
Contraindications
: Known hypersensitivity to any of the listed ingredients.
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.
Storage & 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.
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