Urea
Active ingredient · 2 therapeutic classes
Sold as Evara · UREDEX · HEEL BALM
- Drug class
- Solutions Producing Osmotic Diuresis
- Availability
- Prescription only
- Routes
- Topical
- Markets covered
- 3
- Products on record
- 10
- FDA reports (12 mo)
- 164
Overview
Plain-language summary, compiled from the cited regulatory records
Urea is a medication classified as a solution producing osmotic diuresis [1]. It is approved for debridement and to promote the healing of hyperkeratotic surface lesions, especially when healing is hindered by local infection, necrotic tissue, or debris [1].
This active ingredient is also used to treat various hyperkeratotic conditions. These include dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns, calluses, and damaged, ingrown, or devitalized nails [1].
Urea is available under several brand names, including Evara, UREDEX, and UREA [1]. In the past 12 months, there have been 164 adverse event reports associated with this ingredient [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 7 | May 1, 2026 |
| GB United Kingdom | MHRA | 2 | February 23, 2018 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
USUnited States· FDA
7 products
Uses
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.
How to take
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.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 164 reports total. [4]
- Diarrhoea 22
- Dyspnoea 22
- Off Label Use 22
- Arthralgia 17
- Asthenia 17
- Decreased Appetite 16
- Fatigue 16
- Joint Swelling 16
- Drug Ineffective 15
- Peripheral Swelling 15
- Pruritus 15
- Rash 15
Side effects & warnings
Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. gov/medwatch .
Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
Contraindications Known hypersensitivity to any of the listed ingredients.
This is not medical advice. Consult a qualified healthcare professional.
Brands in United States (3)
GBUnited Kingdom· MHRA
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].
CACanada· Health Canada
1 product
1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Brands in Canada (1)
Drug interactions
Known interactions involving Urea. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 0920f780-b504-1f… · revised January 15, 2026 [PDF]
- [2]MHRA (UK) · PL218280671 · revised February 23, 2018
- [3]Health Canada (DPD) · 02371561 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.