Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 28.35 g (1 oz.) bottles, NDC 39328-019-01 85 g (3 oz.) bottles, NDC 39328-019-03 198.4 g (7 oz.) bottles, NDC 39328-019-07; PRINCIPAL DISPLAY PANEL - 28.35 g Bottle Carton NDC 39328-019-01 Urea 40% Topical Cream For External Use Only Not for Ophthalmic Use Rx Only Net Wt. 28.35 g (1 oz.) PATRIN PHARMA Chemical Structure
- HOW SUPPLIED 28.35 g (1 oz.) bottles, NDC 39328-019-01 85 g (3 oz.) bottles, NDC 39328-019-03 198.4 g (7 oz.) bottles, NDC 39328-019-07
- PRINCIPAL DISPLAY PANEL - 28.35 g Bottle Carton NDC 39328-019-01 Urea 40% Topical Cream For External Use Only Not for Ophthalmic Use Rx Only Net Wt. 28.35 g (1 oz.) PATRIN PHARMA Chemical Structure
Overview
Each gram contains 400 mg of urea in a vehicle 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 chemical structure: Chemical 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 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 people with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse Reactions
Transient stinging, burning, itching or irritation may occur and will normally disappear upon discontinuing the use of this product.
Storage & Handling
STORAGE Store at 20–25°C (68–77ºF), excursions permitted to 15–30ºC (59–86ºF). Protect from freezing and excessive heat. Keep bottle tightly closed
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