MedPath

Urea

Generic Name
Urea
Brand Names
Cem-urea, Umecta, Utopic
Drug Type
Small Molecule
Chemical Formula
CH4N2O
CAS Number
57-13-6
Unique Ingredient Identifier
8W8T17847W

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.

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
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
2025/06/10
NCT07012343
Not Applicable
Active, not recruiting
Chulalongkorn University
The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
2024/09/04
NCT06583369
Not Applicable
Recruiting
Peking University Cancer Hospital & Institute
Adding Urea to the Final Dialysis Fluid
2024/04/15
NCT06366230
Phase 1
Not yet recruiting
University of California, San Francisco
Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial
2024/03/08
NCT06299670
Phase 4
Recruiting
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome
2022/04/27
NCT05348278
Phase 2
UNKNOWN
Mahidol University
Urea for Chronic Hyponatremia
2020/10/19
NCT04588207
Phase 2
Terminated
Helbert Rondon Berrios, MD, MS
Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage
2020/09/17
NCT04552873
Not Applicable
Active, not recruiting
University Hospital, Grenoble
Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia
2020/03/10
NCT04301336
Phase 2
Completed
Beni-Suef University
Comparison of 12% Ammonium Lactate and 10% Urea Cream in Geriatric With Xerosis Cutis
2019/10/15
NCT04127513
Phase 3
Completed
Indonesia University
The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction
2017/07/11
NCT03212625
Phase 4
Completed
Korea University Guro Hospital

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Urea 39% Cream
BioComp Pharma, Inc.
44523-801
TOPICAL
390 mg in 1 g
3/6/2024
Umecta Mousse Urea
Innocutis Holdings LLC
68712-020
TOPICAL
400 mg in 1 g
12/23/2011
UREA 40%
Gabar Health Sciences Corp.
82429-308
TOPICAL
40 g in 100 g
10/21/2023
Urea 39.5% with 2% Salicylic Acid
PureTek Corporation
59088-210
TOPICAL
39.5 g in 100 g
3/24/2023
Urea Cream 40 Percent
Bryant Ranch Prepack
72162-2203
TOPICAL
400 mg in 1 g
12/19/2023
Xurea
NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY
72678-034
TOPICAL
390 mg in 1 g
9/24/2019
Urea
Exact-Rx, Inc.
42808-204
TOPICAL
450 mg in 1 mL
10/23/2023
Urea Cream 41%
Canton Laboratories
69437-341
TOPICAL
410 mg in 1 g
10/26/2023
Urea 40 Percent
Bryant Ranch Prepack
63629-9266
TOPICAL
400 mg in 1 g
4/18/2022
Not Applicable
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
ICM PHARMA PTE. LTD.
SIN02881P
CREAM
5% w/w
5/22/1989
AXCEL UREA CREAM 10% w/w
KOTRA PHARMA (M) SDN BHD
SIN10864P
CREAM
10% w/w
4/7/1999
UCORT CREAM
Y S P INDUSTRIES (M) SDN BHD
SIN08726P
CREAM
100 mg/g
5/27/1996
U O CREAM 10%
Y S P INDUSTRIES (M) SDN BHD
SIN08347P
CREAM
100 mg/g
9/19/1995

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
UREA CREAM 10% W/W
N/A
MARCHING PHARMACEUTICAL LIMITED
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
iNOVA Pharmaceuticals (Hong Kong) Limited
N/A
N/A
6/5/1995

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Hamilton Urederm
326185
Key Pharmaceuticals Pty Ltd
Medicine
A
11/12/2019
Hamilton Urederm
409944
Key Pharmaceuticals Pty Ltd
Medicine
A
6/2/2023
Aquacare/HP Urea 100mg/g Cream
23199
AbbVie Pty Ltd
Medicine
A
10/14/1991
Fuyunhon
153030
Sphere Healthcare Pty Ltd
Medicine
A
6/12/2008

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
HEEL BALM
tanta pharmaceuticals inc
02371561
Cream - Topical
10.0 %
N/A
CARBAMEX 330MGMS
therapeutic foods co.
00190772
Tablet - Oral
330 MG
12/15/1989
UREA
dolisos canada inc.
02234786
Granules ,  Globules ,  Liquid - Oral
1 X
1/5/1998
TI-U-LAC LOTION
merit industries inc.
00505749
Lotion - Topical
10 %
12/31/1980
UREMOL HC
GlaxoSmithKline Inc
00560022
Lotion - Topical
10 %
12/31/1983
THOMAS FORMULA NO 47
thomas hair and scalp specialists
00289469
Liquid - Topical
1.6988 %
12/31/1974
UREA GRANULE (1CH-30CH)
homeocan inc.
01953184
Tablet - Oral
1 CH
12/31/1991
UREMOL HC
GlaxoSmithKline Inc
00503134
Cream - Topical
10 %
12/31/1981
UREMOL 10 CRM 10%
trans canaderm inc.
00687049
Cream - Topical
10 %
12/31/1987
CALMURID CRM
galderma canada inc
02010941
Cream - Topical
100 MG / G
12/31/1994

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
SOLUBALM 0,5 mg/g + 100 mg/g CREMA
Arafarma Group S.A.
53774
CREMA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
UREA NM 15 G POLVO PARA SOLUCION ORAL
Nutricion Medica S.L.
81871
POLVO PARA SOLUCIÓN ORAL
Diagnóstico Hospitalario
Commercialized
CANESMYCOSPOR ONICOSET 10mg/ g + 400mg/g POMADA
Bayer Hispania S.L.
59748
POMADA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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