Umecta Mousse

There are many brands and forms of urea topical available and not all brands are listed on this leaflet.

Urea topical (for the skin) is used to soften rough or dry skin caused by skin conditions such as eczema, psoriasis, keratosis, and others. Urea topical is also used to soften damaged fingernails or toenails so they can be removed without surgery.

Urea topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use urea topical if you are allergic to it.

FDA pregnancy category C. It is not known whether urea topical will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether urea topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using urea topical and call your doctor at once if you have:

• severe redness or irritation of treated skin.

Common side effects may include:

• mild itching; or
• mild burning or stinging.

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

Do not use this medicine on open wounds, burns, or areas of swollen skin. If this medication gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

It is not likely that other drugs you take orally or inject will have an effect on topically applied urea. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

The mechanism of action of topically applied urea is not yet known.

For 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. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.
• Burning.
• Stinging.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Umecta Mousse may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.