Hydro 35

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.

Urea topical is available in many different forms (cream, lotion, ointment, liquid, gel, foam, shampoo, and others) for use on the skin or the scalp. Use your medicine exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Urea topical is for use only on the skin. If this medication gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Use a mild soap or cleanser to wash the skin or nail area to be treated. Urea topical may work best if the skin or nail to be treated is left slightly damp before the medicine is applied.

Apply a thin layer of this medicine to the affected skin and rub it in as completely as possible.

When applying urea topical to the nails, avoid getting any medicine on the cuticles or surrounding skin. Apply generously to the nail and allow the medicine to dry. You may cover the nail with a bandage or gauze if your doctor advises. The treated nail should be easily removed after several days.

Shake the urea topical foam well just before each use. Other forms of this medicine may also need to be shaken before use. Follow all directions on th medicine label.

Wash your hands with soap and water after applying this medicine, unless you are treating the skin on your hands.

Call your doctor if your symptoms do not improve, or if they get worse while using urea topical.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine container tightly closed when not in use.

Keep the foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty foam canister.

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

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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.

• It is used to moisturize skin.
• It is used to treat some nail problems.

• Tell all of your health care providers that you take Hydro 35. This includes your doctors, nurses, pharmacists, and dentists.
• Do not put on irritated skin.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• If you use this medicine too often, your skin problem may become worse.
• Do not use longer than you have been told by the doctor.
• Talk with your doctor before you use other drugs or products on your skin.
• This medicine may catch on fire. Do not use near an open flame or while smoking.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Hydro 35 while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Hydro 35 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 Hydro 35. 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.

Review Date: October 4, 2017

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 Hydro 35 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.