Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: This product is supplied in the following size(s): 8 oz. (226.8 g) bottles, NDC 81542-201-08 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Bantry Pharma, LLC 1000 N. West Street, Suite 1200 Wilmington, DE 19801 2100565 [00] Rev. 09/2021; label
- HOW SUPPLIED: This product is supplied in the following size(s): 8 oz. (226.8 g) bottles, NDC 81542-201-08 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Bantry Pharma, LLC 1000 N. West Street, Suite 1200 Wilmington, DE 19801 2100565 [00] Rev. 09/2021
- label
Overview
Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION: This product is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 400 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, sodium hydroxide, water and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: structure
Indications & Usage
INDICATIONS: 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 pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.
Dosage & Administration
: Apply to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
Warnings & Precautions
WARNINGS: KEEP OUT OF REACH OF CHILDREN.
Contraindications
: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse Reactions
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Storage & Handling
STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. The product may tend to darken in color on storage. The discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed.
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