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| Product NDC Code | 42808-202 | ||||
|---|---|---|---|---|---|
| Drug Name | Urea |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 835837 | ||||
| Labeler Name | Exact-Rx, Inc. | ||||
| 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 on discontinuing medication. Call your doctor for medical advice about side effects.
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. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual removal of devitalized nail plate tissue.
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: Known hypersensitivity to any of the listed ingredients.
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: UREA CREAM 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 45% Urea in a cream base of: camphor, edetate disodium, alcohol, eucalyptus oil, hydroxyethyl cellulose, menthol, purified water, titanium dioxide, sodium hydroxide. CHEMISTRY: Urea is a diamide of carbonic acid with the following chemical structure: 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 ADMINSTRATION: Apply Urea Cream 45% to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.
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 AND USES: Urea 45% Cream is indicated for use in the topical treatment 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, keratoderma, corns and calluses, as well as damaged devitalized and ingrown nails.
Spl product data elements
Usually a list of ingredients in a drug product.UREA UREA WATER WHITE PETROLATUM CAMPHOR (SYNTHETIC) EDETATE DISODIUM ALCOHOL EUCALYPTUS OIL GLYCERIN MENTHOL GLYCERYL STEARATE SE PEG-100 STEARATE MINERAL OIL UREA UREA CETYL ALCOHOL STEARYL ALCOHOL
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 Urea cream Urea Insert
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.(in a cream base) Rx only For external use only. Not for ophthalmic use. Keep away from 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 or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea Cream 45% 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: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea Cream 45% should be given to a pregnant woman only if clearly needed.
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: Urea Cream 45% is supplied in 9 oz. (255 g) tubes, NDC 42808-0202-09.
Storage and handling
Information about safe storage and handling of the drug product.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). See USP Controlled Room Temperature. Protect from freezing.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS: Use this medication only as directed by a physician. It should not be used to treat and condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN .
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. Avoid contact with eyes, lips or mucous membranes. If swallowed seek medical attention or contact a Poison Control Centter immediately.
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