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| Product NDC Code | 58657-487 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Urea 40 percent |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| RxCUI drug identifier | 198342 | ||||||||
| Labeler Name | Method Pharmaceuticals, LLC | ||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin. Pharmacokinetics: The mechanism of action of topically applied urea is not yet known.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmacokinetics: The mechanism of action of topically applied urea is not yet known.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION: 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. structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION: Use as directed by your physician. See label booklet for full Prescribing Information.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Urea 40 Percent Urea GLYCERIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL WHITE PETROLATUM MINERAL OIL WATER GLYCERYL STEARATE SE UREA UREA
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL 1 3 7
Urea 40 Percent: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.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.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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
Safe handling warning
Safe Handling WarningSTORAGE: Store at room temperature 15°C-30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API