Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: This product is supplied in the following size(s): 3 oz, 1 oz, and 7oz To report a serious adverse event or obtain product information, call 877-250-3427 To report a serious adverse event, please contact Method Pharmaceuticals at (877) 250-3427; email at [email protected]; or call FDA at (800) FDA-1088. Manufactured for: Method Pharmaceuticals, LLC Fort Worth, Texas 76118 Rev. 11/21; PRINCIPAL DISPLAY PANEL label1 label2 label3
- HOW SUPPLIED: This product is supplied in the following size(s): 3 oz, 1 oz, and 7oz To report a serious adverse event or obtain product information, call 877-250-3427 To report a serious adverse event, please contact Method Pharmaceuticals at (877) 250-3427; email at [email protected]; or call FDA at (800) FDA-1088. Manufactured for: Method Pharmaceuticals, LLC Fort Worth, Texas 76118 Rev. 11/21
- PRINCIPAL DISPLAY PANEL label1 label2 label3
Overview
INGREDIENTS: Each gram of Urea Cream 40% contains Urea 40% and the following inactive ingredients: Carbomer, Cetearyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, White Petrolatum. desc
Indications & Usage
INDICATIONS: This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
Dosage & Administration
: Use as directed by your physician. See label booklet for full Prescribing Information.
Warnings & Precautions
WARNINGS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes. General: This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: Category C . Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
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.
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