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Urea (topical): Drug information

Urea (topical): Drug information
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For additional information see "Urea (topical): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Aquaphilic/Carbamide [OTC];
  • Beta Care Betamide [OTC];
  • CEM-Urea;
  • Cerovel [DSC];
  • DermacinRx Urea;
  • Dermal Therapy Finger Care [OTC];
  • Gordons Urea [OTC];
  • Gormel 10 [OTC];
  • Gormel [OTC];
  • Hydro 40;
  • Keralac [DSC];
  • Lanaphilic/Urea [OTC];
  • Mycocide CX Callus Exfoliator [OTC];
  • Nutraplus [OTC];
  • Protexa [DSC];
  • Rea-Lo [OTC] [DSC];
  • Ultra Mide 25 [OTC];
  • Umecta Mousse;
  • Uramaxin;
  • Urea 20 Intensive Hydrating [OTC];
  • Urea Hydrating [DSC];
  • Urea Nail;
  • Ureacin-10 [OTC];
  • Ureacin-20 [OTC];
  • Uredeb;
  • Uremez-40;
  • Uresol;
  • Utopic [DSC];
  • Xurea
Pharmacologic Category
  • Keratolytic Agent;
  • Topical Skin Product
Dosing: Adult
Hyperkeratotic conditions

Hyperkeratotic conditions: Topical: Apply 1 to 3 times daily.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Transient stinging of the skin

Dermatologic: Burning sensation of skin (transient), pruritus (transient)

Local: Local irritation

Contraindications

Clinically significant hypersensitivity to urea or any component of the formulation

OTC labeling: When used for self-medication, do not use on irritated, infected, or open skin.

Warnings/Precautions

Concerns related to adverse effects:

• Skin reactions: Some products may cause photosensitivity. Use skin protection and limit sun exposure during therapy and for one week after.

Other warnings/precautions:

• Appropriate use: Avoid contact with eyes, lips, and mucous membranes. Discontinue use if redness, discomfort, or irritation occurs.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

DermacinRx Urea: 41% (227 g) [contains cetyl alcohol, methylparaben, propylene glycol]

Gordons Urea: 40% (120 g) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]

Gormel: 20% (75 g, 120 g, 480 g, 2400 g) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]

Keralac: 47% (142 g [DSC]) [contains edetate (edta) disodium, menthol]

Mycocide CX Callus Exfoliator: 12% (100 mL) [contains methylparaben, propylene glycol, propylparaben]

Nutraplus: 10% (85 g, 453 g) [odorless; contains cetearyl alcohol, methylparaben, propylene glycol, propylparaben]

Protexa: 42% (45 g [DSC]) [contains almond oil, cetearyl alcohol, propylene glycol]

Rea-Lo: 30% (227 g [DSC], 59 mL [DSC])

Urea 20 Intensive Hydrating: 20% (85 g) [contains cetyl alcohol, propylene glycol, trolamine (triethanolamine)]

Urea 20 Intensive Hydrating: 20% (85 g) [contains propylene glycol]

Ureacin-20: 20% (113.4 g)

Uredeb: 39% (227 g) [contains butylparaben, cetyl alcohol, ethylparaben, isobutylparaben, methylparaben, propylene glycol, propylparaben]

Uremez-40: 40% (227 g) [contains butylparaben, cetyl alcohol, ethylparaben, isobutylparaben, methylparaben, propylene glycol, propylparaben]

Uresol: 42.5% (227 g) [contains butylparaben, cetyl alcohol, ethylparaben, isobutylparaben, methylparaben, propylene glycol, propylparaben]

Utopic: 41% (227 g [DSC]) [contains cetyl alcohol, propylene glycol]

Xurea: 39% (227 g) [contains propylene glycol, trolamine (triethanolamine)]

Generic: 10% (85 g [DSC]); 20% (85 g); 39.5% (227 g); 40% (28 g, 28.35 g, 85 g, 198 g, 198.4 g); 41% (227 g); 45% (255 g); 47% (142 g); 39% (226.8 g, 227 g)

Foam, External:

Hydro 40: 40% (150 g) [contains ethylparaben, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]

Umecta Mousse: 40% (113.4 g) [contains soya sterol, trolamine (triethanolamine)]

Urea Hydrating: 35% (150 g [DSC]) [contains ethylparaben, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]

Generic: 35% (227 g)

Gel, External:

Uramaxin: 45% (28 mL) [contains edetate (edta) disodium, menthol, propylene glycol]

Urea Nail: 45% (28 mL) [contains edetate (edta) disodium, menthol, propylene glycol]

Lotion, External:

Beta Care Betamide: 25% (120 mL, 480 mL)

Cerovel: 40% (325 mL [DSC]) [contains alcohol, usp, trolamine (triethanolamine)]

Dermal Therapy Finger Care: 20% (18 mL)

Gormel 10: 10% (228 g)

Nutraplus: 10% (236 mL, 473 mL) [odorless; contains methylparaben, propylparaben]

Ultra Mide 25: 25% (236 mL) [paraben free; contains cetyl alcohol, edetate (edta) sodium (tetrasodium)]

Ureacin-10: 10% (236.56 mL)

Generic: 10% (177 mL [DSC], 236 mL [DSC]); 20% (177 mL [DSC]); 40% (226.8 g)

Ointment, External:

Aquaphilic/Carbamide: 10% (180 g, 454 g); 20% (454 g)

Lanaphilic/Urea: 10% (454 g); 20% (454 g)

Solution, External:

CEM-Urea: 45% (20 mL) [contains edetate (edta) disodium, menthol, methylparaben, propylene glycol]

Generic Equivalent Available: US

May be product dependent

Pricing: US

Cream (DermacinRx Urea External)

41% (per gram): $17.41

Cream (Nutraplus External)

10% (per gram): $0.17

Cream (Urea External)

20% (per gram): $0.10

39% (per gram): $1.29

39.5% (per gram): $8.71

40% (per gram): $0.12 - $2.14

41% (per gram): $3.60

45% (per gram): $0.67

47% (per gram): $4.52

Cream (Uredeb External)

39% (per gram): $16.49

Cream (Uresol External)

42.5% (per gram): $19.92

Foam (Hydro 40 External)

40% (per gram): $1.66

Foam (Umecta Mousse External)

40% (per gram): $2.81

Foam (Urea External)

35% (per gram): $13.95

Gel (Uramaxin External)

45% (per mL): $11.35

Lotion (Beta Care Betamide External)

25% (per mL): $0.06

Lotion (Dermal Therapy Finger Care External)

20% (per mL): $0.30

Lotion (Nutraplus External)

10% (per mL): $0.07

Lotion (Ultra Mide 25 External)

25% (per mL): $0.12

Lotion (Urea External)

40% (per gram): $0.06 - $0.82

Ointment (Aquaphilic/Carbamide External)

10% (per gram): $0.04

20% (per gram): $0.03

Ointment (Lanaphilic/Urea External)

10% (per gram): $0.03

20% (per gram): $0.03

Solution (CEM-Urea External)

45% (per mL): $13.98

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: Apply to affected area; rub in until completely absorbed. May cover with adhesive bandage/gauze or plastic film. Shake lotion and foam vigorously before administering dose.

Use: Labeled Indications

Hyperkeratotic conditions: 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; treatment of hyperkeratotic conditions, such as dry, rough skin; skin cracks and fissures; dermatitis; psoriasis; xerosis; ichthyosis; eczema; keratosis; keratoderma; corns and calluses; damaged, ingrown, and devitalized nails.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Reproduction studies have not been conducted with all products. When conducted, adverse events were not observed in animal studies.

Breastfeeding Considerations

It is not known if urea is found in breast milk. The manufacturer recommends caution be used if administered to nursing women.

Mechanism of Action

Urea softens hyperkeratotic areas by dissolving the intracellular matrix, resulting in loosening the horny layer of the skin, or softening and debridement of the nail plate

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Aquathenol plus | Nutraplus | Ureativ | Urecare;
  • (AR) Argentina: Dayplus | Factor ae urea | Hidroplus | Keratopic | Lociherp | Lociherp liposomas | Nutralcon | Nutraplus m | Panaderm | Ureadin | Ureadin Facial | Urecrem hidro | Uremol | Xerobase;
  • (AT) Austria: Calmurid comp;
  • (AU) Australia: Aquacare | Aqueous buf c urea | Eulactol | Hamilton skin therapy | Heel balm platinum | Nutraplus | Urecare | Urecare 10% euro | Urederm | Uroderm;
  • (BD) Bangladesh: Equra | Eucera | Eudrate | Eukrim;
  • (BE) Belgium: Calmurid;
  • (BG) Bulgaria: Keratolin | Linola Urea;
  • (BR) Brazil: Dardia | Emoderm | Eucerin Pele Seca | Hidrapel | Hidrapel plus | Hidrat | Iso urea | Keratosane | Nutraplus | Ureadin | Uremol | Urepel | Ureskin;
  • (CH) Switzerland: Cremolan | Excipial u;
  • (CL) Chile: Ayr | Ayr con urea | Eucerin | Eucerin Piel Seca | Hyderm | Laceran | Nutracel | Nutraplus | Uramol | Ureadin | Ureadin RX | Urealeti;
  • (CN) China: Wei sheng su B12 niao su;
  • (CO) Colombia: Eucerin urea | Nutraplus | Psorilys | Ureaderm | Ureadin RX | Urealac;
  • (CZ) Czech Republic: Excipial u | Linola Urea;
  • (DE) Germany: Balisa | Basodexan | Callusan | Carbamid widmer | Elacutan | Harnstoff | Harnstoffsalbe | Hyanit | Hydraplex | Laceran | Linola Urea | Nubral | Onychomal | Onyster | Penaderm | Rubio n | Sanavita urea | Urea acis | Ureotop;
  • (DO) Dominican Republic: Carmol | Eucerin urea | Nutraplus | Uramol | Ureativ;
  • (EC) Ecuador: Eucerin Piel Seca | Eucerin urea | Hidrat | Hidribet | Ketoderm plus | Queratol | Quimolox | Ureaderm | Ureadin | Ureativ;
  • (EE) Estonia: Elacutan | Eucerin | Eucerin ph-5 | Eucerin urea | Excipial u | Laceran | Linola Urea | Proxera psomed 40 | Psorilys;
  • (EG) Egypt: Carbamide | Macro carbamide | Urecare;
  • (ES) Spain: Tractopon;
  • (FI) Finland: Apobase carbamide | Canespro nail | Carmi;
  • (GB) United Kingdom: Aquadrate | Eucerin | Eucerin urea | Flexitol | Nutraplus | Sential e;
  • (GT) Guatemala: Umec t;
  • (HK) Hong Kong: Caruderma | Euderm | Fuyunhon | Nutraplus | Urecare | Urederm | Ureson;
  • (HU) Hungary: Linola Urea;
  • (ID) Indonesia: Calmuderm | Carmed | Moisderm | Nutraplus | Soft u | Urederm;
  • (IE) Ireland: Aquadrate | Eucerin | Eucerin urea;
  • (IN) India: Ureativ;
  • (IT) Italy: Eubos Urea | Eutrosis 45 | Idrovel 40 | Keratoderm | Proxera psomed 20 | Proxera psomed 40 | Ureadin ultra 40;
  • (JO) Jordan: Carmol | Moistphil | Nutraplus | Urelol;
  • (JP) Japan: Acetylol | Aquameal | Carederm | Ectema | Kanebo u | Kerabens | Keratinamin | Keratinamin kowa | Menturm nurudakede | Urea iwaki | Urea mylan | Urea zepharma | Urepearl | Urimox | Widecall | Yuria | Yuriderm;
  • (KE) Kenya: Equra;
  • (KR) Korea, Republic of: Bandre | Bodran | Bodurea | Bosom | Bosven | Chochokan | Chokchokan | Green bodol | Hanmi urea | Luna | Manzil | Mimona | Sofrin | Softis | Softya | Sonbaren | Taiguk urea | Withus urea | Yougreen | YouGreen f | Yuvron;
  • (KW) Kuwait: Carbamide | Nutraplus;
  • (LT) Lithuania: Basodexan | Carbamid | Eucerin | Excipial u | Flexitol | Laceran | Linola Urea | Maxiderma;
  • (LU) Luxembourg: Calmurid | Onychomal;
  • (LV) Latvia: Elacutan | Eucerin | Eucerin urea | Excipial u | Linola Urea;
  • (MX) Mexico: Dermakeri | Dermoplast | Eucerin urea | Hidribet | Karmosan | Nutraplus | Uramol | Ureadin | Uretiv;
  • (MY) Malaysia: Balneum Intensive | Euderm | Nutraplus | Uo | Urecare;
  • (NL) Netherlands: Calmurid;
  • (NO) Norway: Karbamid NAF;
  • (NZ) New Zealand: Aquacare | Aquacare HP | HealthE urea | Nutraplus;
  • (PE) Peru: Eucerin | Eucerin urea | Uramol | Ureadin | Ureadin RX | Ureativ;
  • (PH) Philippines: Nutraplus;
  • (PK) Pakistan: Uroderm;
  • (PL) Poland: Cerkoderm40 | Cremobaza | Elacutan | Elacutan f;
  • (PR) Puerto Rico: 45% urea lotion | 45% urea nail gel | Aluvea | Carmol | Carmol 20 | Cem urea | Eucerin | Hydro | Keralac | Keratol | Kerol | Kerol Zx | Mectalyte | Metopic | Nutraplus | Re U40 | U Kera | Umecta | Uramaxin | Uramaxin Gt | Ure k | Urealac | Vanamide | X viate;
  • (PT) Portugal: Ureia;
  • (PY) Paraguay: Eucerin complete repair 5% urea | Keratopic | Xerobase;
  • (QA) Qatar: Carbamid | Eucerin Dry Skin Relief | Eucerin UreaRepair Plus | Qrex | Urelia;
  • (RU) Russian Federation: Foretal | Uroderm;
  • (SA) Saudi Arabia: Calmurid | Carmol;
  • (SE) Sweden: Canoderm | Canoderm Lipid | Caress | Karbamid aco | Karbamid Eucerin | Karbamid evolan;
  • (SG) Singapore: Aqurea | Axcel urea | Euderm | Nutraplus | Uo | Urecare;
  • (SI) Slovenia: Excipial u | Excipial U Lipolotio;
  • (SK) Slovakia: Excipial u | Linola Urea | Ureagamma;
  • (TH) Thailand: Diabederm | Eucerin | Eucerin urea | Nutraplus | Philo soft urea | Uo;
  • (TR) Turkey: Excipial | Excipial hydro | Nutraplus | Urederm | Urederm lipo | Urepial | Urepial lipo;
  • (TW) Taiwan: Binon | Eurotech urea | Fluco-u | Japson | Nutraplus | Sinpharderm | Sinpharderm keratolytic | U Soft | Urederm | Zoria;
  • (UA) Ukraine: Carboderm | Carboplast;
  • (UG) Uganda: Euderm;
  • (UY) Uruguay: Nutralcon | Pedrylu | S&S;
  • (VE) Venezuela, Bolivarian Republic of: Aquaphar | Carmol | Iso-urea Hydrating | Nutraplus m | Uricrim | Urimet;
  • (ZA) South Africa: Aqua forte | Epy derm u | Eulactol | Flexifoot | Nutraplus | Xeroderm Plus
  1. Umecta Emulsion (urea) [prescribing information]. Charleston, SC: Innocutis Holdings; September 2011.
  2. Uramaxin Cream (urea) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals; November 2011.
  3. Uramaxin Gel (urea) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals; April 2011.
  4. UUramaxin Lotion (urea) [prescribing information]. Fairfield, NJ: Medimetriks Pharmaceuticals; November 2011.
  5. Uresol (urea) [prescribing information]. Las Vegas, NV: Mesora Pharma LLC: received January 2018.
  6. Urevaz (urea) [prescribing information]. Ripley, MS: Sterling-Knight Pharmaceuticals, LLC; June 2020.
  7. Hydro 40 Foam (urea) [prescribing information]. Jamison, PA: Quinnova Pharmaceuticals; December 2012.
  8. Gordon's Urea 40 Ointment (urea) [prescribing information]. Upper Darby, PA: Gordon’s Laboratories; no date.
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