Drugplain

Urea Cream 40 Percent 400 mg/g

Urea · CREAM · Bryant Ranch Prepack

No Recall History
Plain English

Urea cream 40% is a topical prescription medication used to soften and remove dead skin, making it helpful for conditions like dry, thickened, or hardened skin. It works by increasing moisture in the skin and breaking down buildup of dead skin cells.

Key Facts

Brand Name
Urea Cream 40 Percent
Generic Name
Urea
NDC Code (Product)
72162-2203
Manufacturer
Bryant Ranch Prepack
Strength
400 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Marketing Start
10/31/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea184 reports
fatigue173 reports
nausea150 reports
off label use140 reports
drug ineffective109 reports
decreased appetite105 reports
dyspnoea99 reports
vomiting98 reports
rash97 reports
pain92 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

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.

Warnings

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

Contraindications

Contraindications Known hypersensitivity to any of the listed ingredients.

Adverse Reactions

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 .

Frequently Asked Questions

What is Urea Cream 40 Percent used for?

Urea cream 40% is a topical prescription medication used to soften and remove dead skin, making it helpful for conditions like dry, thickened, or hardened skin. It works by increasing moisture in the skin and breaking down buildup of dead skin cells.

Is Urea Cream 40 Percent a controlled substance?

Urea Cream 40 Percent is not classified as a controlled substance by the DEA.

What is the generic name for Urea Cream 40 Percent?

The generic name for Urea Cream 40 Percent is Urea. There are 10 other brand versions of Urea.

What is the NDC code for Urea Cream 40 Percent 400 mg/g?

The NDC (National Drug Code) for Urea Cream 40 Percent 400 mg/g is 72162-2203, listed by Bryant Ranch Prepack.

Product NDC

72162-2203

Package NDC

72162-2203-4

Other Urea Cream 40 Percent Dosages

Other Urea Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)