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
Urea is an active pharmaceutical ingredient in the Solutions Producing Osmotic Diuresis group (B05BC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
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
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.