UREA CREAM 40 PERCENT- urea cream

Urea Cream 40 Percent by

Drug Labeling and Warnings

Urea Cream 40 Percent by is a Prescription medication manufactured, distributed, or labeled by Method Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients:

Carbomer, Cetearyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, Purified Water, White Petrolatum.

Urea is a diamide of carbonic acid with the following chemical structure:

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.

Indications and Usage

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 pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings

For topical use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

This medication 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.

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 40% should be given to a pregnant woman only if clearly needed.

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 40% is administered to a nursing woman.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.

To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at

1-877-250-3427; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage and Administration

Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.

Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

How Supplied

Urea 40% Cream

1 oz. (28.35 g): NDC: 58657-489-01

Urea 40% Cream

3 oz. (85 g): NDC: 58657-489-03

Urea 40% Cream

7 oz. (198.4 g): NDC: 58657-489-07

Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

Manufactured for:

Method Pharmaceuticals, LLC

Southlake, Texas 76092

Rev. 09/23

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UREA CREAM 40 PERCENT 
urea cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 58657-489
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	400 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58657-489-01	28.35 g in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2023
2	NDC: 58657-489-03	85 g in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/31/2023

Labeler - Method Pharmaceuticals, LLC (060216698)