urea

Urea is an emollient used in the treatment of many skin disorders that cause dry, rough, thick, and scaly skin.

Urea is a naturally occurring molecule formed in the liver, the principal end product of the body’s protein metabolism, which is eliminated in the urine. Commercially produced urea is used as an ingredient in topical formulations such as creams, gels, lotions, ointments, and sprays that are available over the counter (OTC) in the U.S. Urea skin products typically contain urea in proportions varying from 10% to 50%.

The outer protective layer of the skin is made up of keratin, a tough protein. The dead skin cells in the outer layer are shed regularly as new cells take their place. In some skin conditions such as eczema, psoriasis, calluses, and others, the skin cells do not shed normally, and the keratinous layer accumulates to form thick plaques or dry, horny scales that can be itchy and painful.

Urea works by gently dissolving the top skin layer’s extracellular matrix, a network of proteins that provide structure to all tissue, softening and loosening the scaly and horny top layer of the skin, and promoting its shedding. Urea is also used to soften and debride abnormally thickened nail plates that result from these skin conditions. Urea products are used in the following skin conditions:

• Dry, rough skin (xerosis)
• Rough, scaly, fish-scale skin (ichthyosis)
• Skin cracks and fissures
• Dermatitis
• Eczema
• Psoriasis
• Keratosis pilaris
• Keratosis palmaris
• Keratoderma
• Corns and calluses
• Damaged, ingrown and devitalized nails

• Do not use it if you are hypersensitive to any of the components in the urea formulation.
• Do not apply urea on irritated, infected or open skin.
• Do not use it to treat any skin condition other than that for which it is prescribed.
• Neither long-term animal studies for carcinogenic potential, nor studies on reproduction and fertility have been performed on this product yet. Use with caution.
• No animal reproductive studies or adequate and well-controlled studies on pregnant women have been performed. Urea should be used during pregnancy only if it is clearly needed and the maternal benefits outweigh potential risks to the fetus.
• It is not known if urea is present in breast milk. Use with caution in nursing mothers, because many drugs are excreted in breast milk.

Common side effects of urea include:

• Local irritation
• Transient stinging of the skin
• Transient burning sensation
• Itching (pruritus)
• Redness
• Rash

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Cream

• 10%
• 20%
• 30%
• 35%
• 40%
• 41%
• 45%
• 50%

Lotion

• 10%
• 20%
• 25%
• 35%
• 40%
• 45%

Gel

• 40%
• 45%
• 50%

Suspension

• 40%
• 50%

Solution

• 50%

Ointment

• 10%
• 20%
• 50%

Emulsion

• 40%
• 45%
• 50%

Aerosol, Foam

• 20%
• 30%
• 35%
• 40%
• 42%

Adult:

Hyperkeratotic Skin Conditions

• Indicated for hyperkeratotic conditions such as dry, rough skin; xerosis; ichthyosis; skin cracks and fissures; dermatitis; eczema; psoriasis; keratoses; and calluses
• Apply topically to affected skin every day or every 8-12 hours

Administration

• Rub lotion/cream into skin until completely absorbed

Pediatric:

• Safety and efficacy not established

Overdose

• Applying too much urea products on the skin can cause irritation, redness, itching and pain. Symptoms should resolve with discontinuation of urea.
• Urea inhalation can cause coughing and shortness of breath and eye exposure can irritate the eye and cause pain and redness.
• Oral overdose of urea may cause nausea, vomiting, diarrhea, headache, confusion and electrolyte depletion.
• Treatment of urea overdose is symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Urea has no known severe or serious interactions with other drugs.
• Moderate Interactions of urea include:
  • collagenase
• Mild Interactions of urea include:
  • vasopressin

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.