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Urea (Topical)

Pronunciation

(yoor EE a)

Index Terms

  • Carbamide

Dosage Forms

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

Cream, External:

Aluvea: 39% (227 g [DSC])

Atrac-Tain: 10% (2 g, 57 g, 142 g)

Carb-O-Lac5: Urea 20% and Ammonium Lactate 10% (236 g [DSC]) [contains propylene glycol]

Carb-O-Lac HP: Urea 20% and Ammonium Lactate 10% (277 g [DSC]) [contains propylene glycol]

Carb-O-Philic/10: 10% (410 g [DSC]) [contains propylene glycol]

Carb-O-Philic/20: 20% (85 g [DSC]) [contains propylene glycol]

Carb-O-Philic/40: 40% (85 g [DSC], 200 g [DSC]) [contains cetyl alcohol, propylene glycol, trolamine (triethanolamine)]

Carmol 20: 20% (85 g)

DPM: (170 g) [lanolin free, mineral oil free, paraben free; contains brilliant blue fcf (fd&c blue #1), propylene glycol, tartrazine (fd&c yellow #5), 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) [contains edetate disodium, menthol]

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

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

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

Rea Lo 40: 40% (28.3 g, 85 g, 198.4 g)

Rea Lo 39: 39% (227 g) [fragrance free]

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

Remeven: 50% (142 g, 255 g) [contains disodium edta]

Rynoderm: 37.5% (142 g) [contains disodium edta]

U-Kera E: 40% (28.35 g [DSC], 85.05 g [DSC], 198.45 g [DSC]) [contains trolamine (triethanolamine)]

Uramaxin: 45% (255 g) [contains alcohol, usp, edetate disodium, menthol]

Ure-K: 50% (142 g) [contains disodium edta]

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

Ureacin-20: 20% (113.4 g)

Urevaz: 44% (60 g) [contains disodium edta]

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

X-Viate: 40% (28.3 g [DSC], 85 g [DSC], 199 g [DSC])

Generic: 10% (85 g); 20% (85 g); 40% (28 g, 28.35 g, 85 g, 85.05 g, 198 g, 198.4 g, 198.6 g); 45% (255 g); 47% (142 g); 50% (142 g, 255 g); 39% (226.8 g, 227 g)

Emulsion, External:

Latrix XM: 45% (240 mL) [contains cetyl alcohol, disodium edta, propylene glycol, trolamine (triethanolamine)]

Umecta: 40% (120 g, 227 g) [contains trolamine (triethanolamine)]

Umecta PD: 40% (198.5 g) [contains disodium edta, glycine soja (soybean) sterol]

Generic: 50% (284 g, 300 g)

Foam, External:

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

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

Kerafoam: 30% (60 g [DSC], 100 g [DSC]) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben]

Kerafoam 42: 42% (60 g [DSC], 100 g [DSC]) [contains cetearyl alcohol, edetate disodium, methylparaben, propylene glycol, propylparaben]

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

Uramaxin: 20% (100 g) [contains cetyl alcohol, propylene glycol]

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

Gel, External:

Carb-O-Philic/40: 40% (15 g [DSC]) [contains disodium edta, trolamine (triethanolamine)]

Cerovel: 40% (25 mL)

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

Uramaxin GT: 45% (20 mL) [contains edetate disodium, menthol, propylene glycol]

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

X-Viate: 40% (15 mL [DSC]) [contains methylparaben]

Generic: 40% (15 mL)

Kit, External:

Dermasorb XM: 39% [contains ceteareth-20, cetyl alcohol, chlorocresol (chloro-m-cresol)]

Uramaxin GT: 45% [contains edetate disodium, menthol, propylene glycol]

Urea Nail: 40 & 0.2 % [contains disodium edta, methylparaben, propylparaben, trolamine (triethanolamine)]

Lotion, External:

Atrac-Tain: 5% (118 mL, 237 mL)

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

Carmol 10: 10% (177 mL)

Cerovel: 40% (325 mL) [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]

Rea Lo 40: 40% (236.6 mL) [fragrance free]

Rea-Lo: 15% (120 mL)

TL Urea: 45% (480 g [DSC]) [contains alcohol, usp, edetate disodium, menthol]

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

Uramaxin: 45% (480 g) [contains alcohol, usp, edetate disodium, menthol]

Urea-C40: 40% (236.6 mL)

Ureacin-10: 10% (236.56 mL)

X-Viate: 40% (237 mL [DSC]) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]

Generic: 10% (180 mL, 240 mL, 480 mL); 40% (226.8 g, 236.6 mL); 45% (480 g)

Ointment, External:

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

Gordons Urea: 22% (30 g); 40% (30 g)

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

Shampoo, External:

Carmol: 10% (240 mL)

Solution, External:

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

Stick, External:

Urea Nail: 50% (2.4 mL) [contains cetyl alcohol, disodium edta]

Suspension, External:

Umecta: 40% (283.4 g) [contains trolamine (triethanolamine)]

Umecta Nail Film: 40% (3 g, 18 mL) [contains disodium edta]

Umecta PD: 40% (255.1 g) [contains disodium edta, glycine soja (soybean) sterol]

Generic: 40% (283.4 g, 18 mL); 50% (284 g)

Brand Names: U.S.

  • Aluvea [DSC]
  • Aquaphilic/Carbamide [OTC]
  • Atrac-Tain [OTC]
  • Beta Care Betamide [OTC]
  • Carb-O-Lac HP [OTC] [DSC]
  • Carb-O-Lac5 [OTC] [DSC]
  • Carb-O-Philic/10 [OTC] [DSC]
  • Carb-O-Philic/20 [OTC] [DSC]
  • Carb-O-Philic/40 [DSC]
  • Carmol 10 [OTC]
  • Carmol 20 [OTC]
  • Carmol [OTC]
  • CEM-Urea
  • Cerovel
  • Dermal Therapy Finger Care [OTC]
  • Dermasorb XM
  • DPM [OTC]
  • Gordons Urea
  • Gordons Urea [OTC]
  • Gormel 10 [OTC]
  • Gormel [OTC]
  • Hydro 35
  • Hydro 40
  • Kerafoam 42 [DSC]
  • Kerafoam [DSC]
  • Keralac
  • Lanaphilic/Urea [OTC]
  • Latrix XM
  • Mycocide CX Callus Exfoliator [OTC]
  • Nutraplus [OTC]
  • Rea Lo 39
  • Rea Lo 40
  • Rea-Lo [OTC]
  • Remeven
  • Rynoderm
  • TL Urea [DSC]
  • U-Kera E [DSC]
  • Ultra Mide 25 [OTC]
  • Umecta
  • Umecta Mousse
  • Umecta Nail Film
  • Umecta PD
  • Uramaxin
  • Uramaxin GT
  • Ure-K
  • Urea 20 Intensive Hydrating [OTC]
  • Urea Hydrating
  • Urea Nail
  • Urea-C40
  • Ureacin-10 [OTC]
  • Ureacin-20 [OTC]
  • Urevaz
  • Utopic
  • X-Viate [DSC]

Pharmacologic Category

  • Keratolytic Agent
  • Topical Skin Product

Pharmacology

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

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.

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.

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing.

Administration

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

Storage

Cream, lotion, gel, ointment: Store at room temperature (15°C to 30°C [59°F to 86°F]). Protect from freezing.

Foam: Store at room temperature (15°C to 30°C [59°F to 86°F]). Protect from freezing. Do not expose aerosol foam to temperatures over 48°C (120°F); do not puncture or incinerate.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Central nervous system: Transient stinging of the skin

Local: Local irritation

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.

Pregnancy Risk Factor

B/C (manufacturer specific)

Pregnancy Considerations

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

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning, stinging, or itching. Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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