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Urea - Medication Information

Product NDC Code 24470-938
Drug Name

Urea

Type Generic
Active Ingredients
Urea 390 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 1093289
Labeler Name Cintex Services, LLC
Packages
Package NDC Code Description
24470-938-08 227 g in 1 bottle, plastic (24470-938-08)
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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.

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.
Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. DESCRIPTION: This product is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 390 mg of urea in a vehicle consisting 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 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 ADMINISTRATION: Apply to affected area(s) twice per day or as directed by a physician. Rub in until 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: 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 UREA 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.
label

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: 8 oz. (227 g) bottles, NDC 24470-938-08 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Cintex Services, LLC 9330 LBJ Freeway, Suite 900 Dallas, TX 75243 2300393 [00] Rev. 12/2023

Storage and handling

Information about safe storage and handling of the drug product.
STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. Keep container tightly closed.

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