Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: 3 oz. (85 g) bottles, NDC 85622-0601-03 To report a serious adverse event or obtain product information, call (813) 380-0271. Manufactured for: Blue Heron Pharmacueticals, LLC 2831 Allegra Way, Suite 218, Lutz, FL 33559 Questions? Call: (813) 380-0271; image description
- HOW SUPPLIED: 3 oz. (85 g) bottles, NDC 85622-0601-03 To report a serious adverse event or obtain product information, call (813) 380-0271. Manufactured for: Blue Heron Pharmacueticals, LLC 2831 Allegra Way, Suite 218, Lutz, FL 33559 Questions? Call: (813) 380-0271
- image description
Overview
Each gram contains 200 mg of urea in a vehicle consisting of: carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure: Figure 1
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 area(s) 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
WARNING: 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. Keep bottle tightly closed.
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