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| Product NDC Code | 42192-115 | ||||
|---|---|---|---|---|---|
| Drug Name | Urea hydrating topical |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| RxCUI drug identifier | 849646 | ||||
| Labeler Name | Acella Pharmaceuticals | ||||
| 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 is possible.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Topically applied urea dissolves the intercellular matrix of the skin which results in enhanced shedding of scaly, dry skin and thus a softening of the hyperkeratotic areas of the skin. Urea topically applied to the nail plate has a similar effect on the intercellular matrix of the nail plate.
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 35% Hydrating Topical Foam is a keratolytic emollient in a water and lipid based foam containing lactic acid which is a gentle, but potent, tissue softener for skin and nails. Each gram of Urea 35% Hydrating Topical Foam contains Urea 35% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, lactic acid, methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane. CHEMICAL STRUCTURE Urea has the following chemical structure: ureachemformula
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 Unless otherwise directed by a prescribing physician, Urea 35% Hydrating Topical Foam should be applied to affected area twice a day. Urea 35% Hydrating Topical Foam should be rubbed into the skin until it is completely absorbed.
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 USAGE For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris, or eschar. Topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, and dry, rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.
Spl product data elements
Usually a list of ingredients in a drug product.UREA HYDRATING TOPICAL UREA DIMETHICONE ETHYLPARABEN GLYCERIN LACTIC ACID METHYLPARABEN PHENOXYETHANOL POLYSORBATE 20 POVIDONE PROPYLENE GLYCOL PROPYLPARABEN WATER STEARIC ACID TROLAMINE BUTANE PROPANE UREA UREA
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.productlabel
NDC 42192-115-15 Urea 35% Hydrating Topical Foam Rx Only Net Wt. 5.3 oz. (150 g) NDC 42192-115-15 Rx Only Net Wt. 5.3 oz. (150 g) Dosage and Administration: Clean and dry affected skin. Then apply Urea 35% Hydrating Topical Foam topically to cover affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Shake vigorously before each application and invert can to administer. Store at room temperature 59° - 77°F (15° - 25°C). See prescribing information for additional details. Ingredients: urea 35%, dimethicone, ethylparaben, glycerin, lactic acid, methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, stearic acid, trolamine, and in propellants butane and propane. Warning: Contents under pressure. Do not puncture or incinerate. Do not expose to temperatures over 120°F (48°C) even when empty. Keep out of reach of children. Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4802 1 2
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.Enter section text here
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 topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering Urea 35% Hydrating Topical Foam to nursing mothers.
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 B) – Animal reproduction studies have not been performed with topically applied urea and it is not known whether Urea 35% Hydrating Topical Foam can cause fetal harm when administered to a pregnant woman. Nevertheless, Urea 35% Hydrating Topical Foam should be used by a pregnant woman only if necessary.
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 35% Hydrating Topical Foam is supplied in a 150 gram or 5.3 ounce aerosolized canister bearing the NDC Number 42192-115-15.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Urea 35% Hydrating Topical Foam should be used only as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. If redness or irritation occurs, discontinue use and consult with a prescribing 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 Urea 35% Hydrating Topical Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips, and all mucous membranes should be avoided. Urea 35% Hydrating Topical Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.
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