Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Urea Nail Gel 45% is supplied in a 28 mL glass bottle NDC 42808-0204-28. Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing. Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747 00-0204-28-205-00 Iss:7/11; 1
- HOW SUPPLIED: Urea Nail Gel 45% is supplied in a 28 mL glass bottle NDC 42808-0204-28. Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing. Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747 00-0204-28-205-00 Iss:7/11
- 1
Overview
UREA Nail Gel 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of UREA Nail Gel 45% contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water. UREA is a diamide of carbonic acid with the following chemical structure:
Indications & Usage
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 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 and ingrown nails.
Dosage & Administration
: Apply Urea Nail Gel 45% to diseased or damaged nail tissue twice per day, or as directed by a physician.
Warnings & Precautions
WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.
Contraindications
: Known hypersensitivity to any of the listed ingredients.
Adverse Reactions
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication. Call your doctor for medical advice about side effects.
Storage & Handling
Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing. Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747 00-0204-28-205-00 Iss:7/11
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