Urea Topical

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.

• Aluvea [DSC]
• Aquaphilic/Carbamide [OTC]
• Atrac-Tain [OTC]
• Beta Care Betamide [OTC]
• Carb-O-Lac HP [OTC] [DSC]
• Carb-O-Lac5 [OTC] [DSC]
• Carb-O-Philic/10 [OTC] [DSC]
• Carb-O-Philic/20 [OTC] [DSC]
• Carb-O-Philic/40 [DSC]
• Carmol 10 [OTC] [DSC]
• Carmol 20 [OTC] [DSC]
• Carmol [OTC] [DSC]
• CEM-Urea
• Cerovel
• Dermal Therapy Finger Care [OTC]
• Dermasorb XM
• DPM [OTC] [DSC]
• Gordons Urea
• Gordons Urea [OTC]
• Gormel 10 [OTC]
• Gormel [OTC]
• Hydro 35
• Hydro 40
• Kerafoam 42 [DSC]
• Kerafoam [DSC]
• Keralac
• Lanaphilic/Urea [OTC]
• Latrix
• Latrix XM
• Mycocide CX Callus Exfoliator [OTC]
• Nutraplus [OTC]
• Rea Lo 39
• Rea Lo 40
• Rea-Lo [OTC]
• Remeven
• Rynoderm
• Salrix
• U-Kera E [DSC]
• Ultra Mide 25 [OTC]
• Umecta Mousse
• Umecta Nail Film [DSC]
• Umecta PD [DSC]
• Umecta [DSC]
• Uramaxin
• Uramaxin GT
• Ure-K
• Urea 20 Intensive Hydrating [OTC]
• Urea Hydrating
• Urea Nail
• Urea-C40
• Ureacin-10 [OTC]
• Ureacin-20 [OTC]
• Urevaz
• Utopic
• X-Viate [DSC]

Urea softens hyperkeratotic areas by dissolving the intracellular matrix, resulting in loosening the horny layer of the skin, or softening and debridement of the nail plate

Clinically significant hypersensitivity to urea or any component of the formulation

OTC labeling: When used for self-medication, do not use on irritated, infected, or open skin.

Concerns related to adverse effects:

• Skin reactions: Some products may cause photosensitivity. Use skin protection and limit sun exposure during therapy and for one week after.

Other warnings/precautions:

• Appropriate use: Avoid contact with eyes, lips, and mucous membranes. Discontinue use if redness, discomfort, or irritation occurs.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning, stinging, or itching. Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Some ways to help prevent dry skin include using lukewarm (not hot) water when bathing, taking baths/showers less often (e.g., every 1-2 days), keeping baths/showers short, and using a humidifier when the air is very dry.

There are many types of emollient products available. Some contain fragrance or other ingredients that some people may be sensitive to. Emollients are available in different forms such as oils, creams, lotions, or sprays. Consult with your doctor or pharmacist on the product that may be best for you.

Missed Dose

If you are using this product on a regular schedule and miss a dose, use it as soon as you remember. Do not use more product or use it more often than directed to catch up.

Storage

Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all drug products away from children and pets.

Do not store the foam canister near high heat (more than 120 degrees F/49 degrees C), and do not store or use it near an open flame. Because foam canisters are under pressure, do not puncture or burn the canister.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised October 2016. Copyright(c) 2016 First Databank, Inc.