Utopic

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.

• Artesa Labs, LLC

Utopic is part of the drug classes:

• Carbamide products

• Solutions producing osmotic diuresis

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.