Drugplain

UREA 400 mg/g

UREA · LOTION · Bantry Pharma, LLC

No Recall History
Plain English

UREA is a lotion containing urea at 400 mg/g, taken topical. Manufactured by Bantry Pharma, LLC.

Key Facts

Brand Name
UREA
Generic Name
UREA
NDC Code (Product)
81542-201
Manufacturer
Bantry Pharma, LLC
Strength
400 mg/g
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Marketing Start
09/07/2021

Recall History

No Recall History

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 used for?

UREA contains UREA. It is a lotion taken topical. Consult your doctor for specific uses.

Is UREA a controlled substance?

UREA is not classified as a controlled substance by the DEA.

What is the generic name for UREA?

The generic name for UREA is UREA. There are 11 other brand versions of UREA.

What is the NDC code for UREA 400 mg/g?

The NDC (National Drug Code) for UREA 400 mg/g is 81542-201, listed by Bantry Pharma, LLC.