Label: UREA CREAM 40 PERCENT- urea cream
- NDC Code(s): 58657-489-01, 58657-489-03
- Packager: Method Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 31, 2023
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- Official Label (Printer Friendly)
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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
- Pharmacokinetics
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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
- Warnings
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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.
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UREA CREAM 40 PERCENT
urea creamProduct 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)