Overview
A compound formed in the liver from ammonia produced by the deamination of amino acids. It is the principal end product of protein catabolism and constitutes about one half of the total urinary solids.
Background
A compound formed in the liver from ammonia produced by the deamination of amino acids. It is the principal end product of protein catabolism and constitutes about one half of the total urinary solids.
Indication
Urea is used topically 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, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails.
Associated Conditions
- Allergic Skin Reaction
- Atopic Dermatitis
- Contact Dermatitis
- Dermatitis
- Dry Eyes
- Dry Skin
- Dry Skin; Eczema
- Eczema, Dyshidrotic
- Eye pruritus
- Helicobacter Pylori Infection
- Insect Bites
- Lichen Planus (LP)
- Neurodermatitis
- Nummular Dermatitis
- Psoriasis
- Seborrheic Dermatitis
- Sunburn
- Anal eczema
- Calluses
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/10 | Not Applicable | Active, not recruiting | |||
2024/09/04 | Not Applicable | Recruiting | Peking University Cancer Hospital & Institute | ||
2024/04/15 | Phase 1 | Not yet recruiting | |||
2024/03/08 | Phase 4 | Recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2022/04/27 | Phase 2 | UNKNOWN | |||
2020/10/19 | Phase 2 | Terminated | Helbert Rondon Berrios, MD, MS | ||
2020/09/17 | Not Applicable | Active, not recruiting | University Hospital, Grenoble | ||
2020/03/10 | Phase 2 | Completed | |||
2019/10/15 | Phase 3 | Completed | |||
2017/07/11 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BioComp Pharma, Inc. | 44523-801 | TOPICAL | 390 mg in 1 g | 3/6/2024 | |
| Innocutis Holdings LLC | 68712-020 | TOPICAL | 400 mg in 1 g | 12/23/2011 | |
| Gabar Health Sciences Corp. | 82429-308 | TOPICAL | 40 g in 100 g | 10/21/2023 | |
| PureTek Corporation | 59088-210 | TOPICAL | 39.5 g in 100 g | 3/24/2023 | |
| Bryant Ranch Prepack | 72162-2203 | TOPICAL | 400 mg in 1 g | 12/19/2023 | |
| NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY | 72678-034 | TOPICAL | 390 mg in 1 g | 9/24/2019 | |
| Exact-Rx, Inc. | 42808-204 | TOPICAL | 450 mg in 1 mL | 10/23/2023 | |
| Canton Laboratories | 69437-341 | TOPICAL | 410 mg in 1 g | 10/26/2023 | |
| Bryant Ranch Prepack | 63629-9266 | TOPICAL | 400 mg in 1 g | 4/18/2022 | |
| Sterling-Knight Pharmaceuticals, LLC | 69336-810 | TOPICAL | 42 mg in 1 g | 2/18/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| HYDROCORTISONE 1% ET UREA 5% CREAM | SIN02881P | CREAM | 5% w/w | 5/22/1989 | |
| AXCEL UREA CREAM 10% w/w | SIN10864P | CREAM | 10% w/w | 4/7/1999 | |
| UCORT CREAM | SIN08726P | CREAM | 100 mg/g | 5/27/1996 | |
| U O CREAM 10% | SIN08347P | CREAM | 100 mg/g | 9/19/1995 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Urea Cream | 国药准字H12020299 | 化学药品 | 乳膏剂 | 8/29/2020 | |
| Urea Cream | 国药准字H44023004 | 化学药品 | 乳膏剂 | 1/17/2020 | |
| Urea Cream | 国药准字H32022105 | 化学药品 | 乳膏剂 | 7/30/2020 | |
| Urea Cream | 国药准字H20074236 | 化学药品 | 乳膏剂 | 6/10/2022 | |
| Urea Cream | 国药准字H32023714 | 化学药品 | 乳膏剂 | 7/24/2020 | |
| Urea Cream | 国药准字H44023443 | 化学药品 | 乳膏剂 | 12/6/2019 | |
| Urea Cream | 国药准字H20063666 | 化学药品 | 乳膏剂 | 12/10/2020 | |
| Urea Cream | 国药准字H32022220 | 化学药品 | 乳膏剂 | 7/7/2020 | |
| Urea Cream | 国药准字H20173050 | 化学药品 | 乳膏剂 | 12/22/2021 | |
| Urea Cream | 国药准字H42020441 | 化学药品 | 乳膏剂 | 9/17/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| UREA CREAM 10% W/W | N/A | N/A | N/A | 7/23/2018 | |
| URMYSUN CREAM 40%W/W | N/A | bright future pharmaceuticals factory o/b bright future pharmaceutical laboratories limited | N/A | N/A | 6/22/2015 |
| DERMA-DRATE CREAM 10% | N/A | N/A | N/A | 6/5/1995 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Hamilton Urederm | 326185 | Medicine | A | 11/12/2019 | |
| Hamilton Urederm | 409944 | Medicine | A | 6/2/2023 | |
| Aquacare/HP Urea 100mg/g Cream | 23199 | Medicine | A | 10/14/1991 | |
| Fuyunhon | 153030 | Medicine | A | 6/12/2008 |