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 [DSC], 57 g [DSC], 142 g [DSC])
Carb-O-Lac5: Urea 20% and Ammonium Lactate 5% (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]
Carmol 20: 20% (85 g [DSC])
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) [contains edetate disodium, menthol]
MeTopic: 41% (227 g [DSC]) [contains cetyl alcohol, methylparaben, propylene glycol, propylparaben]
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]
Rea Lo 40: 40% (28.3 g [DSC], 85 g [DSC], 198.4 g [DSC])
Rea Lo 39: 39% (227 g [DSC]) [fragrance free]
Rea-Lo: 30% (227 g, 59 mL)
Remeven: 50% (142 g [DSC], 255 g [DSC]) [contains disodium edta]
Rynoderm: 37.5% (142 g [DSC]) [contains disodium edta]
Uraliss: 35% (240 g [DSC]) [contains butylparaben, cetyl alcohol, ethylparaben, isobutylparaben, methylparaben, propylene glycol, propylparaben]
Uramaxin: 45% (255 g [DSC]) [contains alcohol, usp, edetate disodium, menthol]
Ure-K: 50% (142 g [DSC]) [contains disodium edta]
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]
Urevaz: 44% (60 g [DSC]) [contains disodium edta]
Utopic: 41% (227 g) [contains cetyl alcohol, propylene glycol]
Xurea: 39% (227 g) [contains propylene glycol, trolamine (triethanolamine)]
Generic: 10% (85 g [DSC]); 20% (85 g [DSC]); 40% (28 g, 28.35 g, 85 g, 198 g, 198.4 g); 41% (227 g); 45% (255 g); 47% (142 g); 50% (142 g [DSC], 255 g [DSC]); 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 [DSC], 227 g [DSC]) [contains trolamine (triethanolamine)]
Umecta PD: 40% (198.5 g [DSC]) [contains disodium edta, glycine soja (soybean) sterol]
Generic: 50% (284 g, 300 g)
Foam, External:
Hydro 35: 35% (150 g [DSC]) [contains ethylparaben, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
Hydro 40: 40% (150 g) [contains ethylparaben, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
Umecta Mousse: 40% (113.4 g) [contains soya sterol, trolamine (triethanolamine)]
Uramaxin: 20% (100 g [DSC]) [contains cetyl alcohol, propylene glycol]
Urea Hydrating: 35% (150 g) [contains ethylparaben, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
Generic: 35% (227 g)
Gel, External:
Uramaxin: 45% (28 mL) [contains edetate disodium, menthol, propylene glycol]
Uramaxin GT: 45% (20 mL [DSC]) [contains edetate disodium, menthol, propylene glycol]
Urea Nail: 45% (28 mL) [contains edetate disodium, menthol, propylene glycol]
Generic: 40% (15 mL [DSC])
Kit, External:
Dermasorb XM: 39% [DSC] [contains ceteareth-20, cetyl alcohol, chlorocresol (chloro-m-cresol)]
Uramaxin GT: 45% [DSC] [contains edetate disodium, menthol, propylene glycol]
Urea Nail: 40% [DSC] [contains disodium edta, methylparaben, propylparaben, trolamine (triethanolamine)]
Lotion, External:
Atrac-Tain: 5% (118 mL [DSC], 237 mL [DSC])
Beta Care Betamide: 25% (120 mL, 480 mL)
Carmol 10: 10% (177 mL [DSC])
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 [DSC]) [fragrance free]
Rea-Lo: 15% (120 mL [DSC])
Ultra Mide 25: 25% (236 mL) [paraben free; contains cetyl alcohol, edetate sodium (tetrasodium)]
Uramaxin: 45% (480 g [DSC]) [contains alcohol, usp, edetate disodium, menthol]
Urea-C40: 40% (236.6 mL)
Ureacin-10: 10% (236.56 mL)
Generic: 10% (177 mL [DSC], 236 mL [DSC], 480 mL [DSC]); 20% (177 mL); 40% (226.8 g, 236.6 mL [DSC]); 45% (480 g [DSC])
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 [DSC])
Solution, External:
CEM-Urea: 45% (20 mL) [contains edetate disodium, menthol, methylparaben, propylene glycol]
Stick, External:
Urea Nail: 50% (2.4 mL [DSC]) [contains cetyl alcohol, disodium edta]
Suspension, External:
Latrix: 50% (284 g [DSC]) [contains cetyl alcohol, edetate disodium, propylene glycol, trolamine (triethanolamine)]
Salrix: 50% (284 g [DSC]) [contains disodium edta]
Umecta Nail Film: 40% (3 g [DSC], 18 mL [DSC]) [contains disodium edta]
Generic: 40% (283.4 g, 18 mL); 50% (284 g [DSC])
Pharmacology
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
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.
Dosage and Administration
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
Dermatologic: Burning sensation of skin (transient), pruritus (transient)
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
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
What is this drug used for?
- It is used to moisturize skin.
- It is used to treat some nail problems.
Frequently reported side effects of this drug
- Burning
- Stinging
- Itching
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Redness or application site irritation
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
