Urea

Urea is an over-the-counter (OTC) product used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness).

Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

Urea is available under the following different brand and other names: Carmol 10, Keralac, Carmol 20, Carmol 40, Gordon's Urea, Aquacare, Ureacin 10, Ureacin 20, Utopic, and Vanamide.

Dosage Forms and Strengths

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%

Dosage Considerations – Should be Given as Follows:

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 once/day or every 8-12 hours

Administration

• Rub lotion/cream into skin until completely absorbed
• Pediatric: Safety and efficacy not established

Common side effects of urea include:

• Local irritation (burning, itching, redness)
• Temporary stinging
• Rash

Serious side effects of urea include:

• Unusual changes in the skin (e.g., blistering, peeling)
• Signs of skin infection

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

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

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains urea. Do not take Carmol 10, Keralac, Carmol 20, Carmol 40, Gordon's Urea, Aquacare, Ureacin 10, Ureacin 20, Utopic, and Vanamide if you are allergic to urea or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity
• Viral skin disease

Effects of Drug Abuse

• Longer use can cause the bowels to stop functioning normally and might cause dependence on laxatives.
• Long-term use can cause changes in blood electrolytes that can cause heart function disorders, muscle weakness, liver damage, and other harmful effects.

Short-Term Effects

• See "What Are Side Effects Associated with Using Urea?"

Long-Term Effects

• Longer use can cause the bowels to stop functioning normally and might cause dependence on laxatives.
• Long-term use can cause changes in blood electrolytes that can cause heart function disorders, muscle weakness, liver damage, and other harmful effects.
• See "What Are Side Effects Associated with Using Urea?"

Cautions

• Ischemic skin necrosis reported with high concentration or irrigation.
• Not for use near the eye.

Pregnancy and Lactation

• Use urea with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is unknown how urea might affect lactation.
• Pregnant or breastfeeding patients should seek advice of health professional before using over-the-counter (OTC) drugs.