Urea 45% Cream -255g

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

UREA (KERATOLYTIC) - TOPICAL

(ue-REE-a)

COMMON BRAND NAME(S): Kerafoam, Keralac, Kerol, Umecta

USES: Urea is used to treat dry/rough skin conditions (e.g., eczema, psoriasis, corns, callus) and some nail problems (e.g., ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.

HOW TO USE: Use this product as directed. Follow all directions on the product package and prescription label. If you have any questions, ask your doctor or pharmacist. Some products need to be shaken well before use. Check the label to see whether you should shake the bottle. Apply to the affected areas of the skin/nails, usually 1 to 3 times a day or as directed by your doctor. Rub in well until absorbed. Wash your hands after applying unless you are treating the hands. How often you apply the medication will depend on the product and your skin condition. Apply to the skin/nails only. Avoid sensitive areas such as your eyes, lips, inside your mouth/nose, and the vaginal/groin area, unless your doctor directs you otherwise. Ask your doctor or check the label for directions about any areas or types of skin where you should not apply the product (e.g., the face, broken/chapped/cut/irritated/scraped skin, or recently shaved skin). Ask your doctor if you should cover the treated area with a bandage or gauze. Consult your doctor or pharmacist for more details. Use this medication regularly to get the most benefit from it. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Burning, itching, stinging, redness, or irritation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: unusual changes in the skin (e.g., blistering, peeling), signs of skin infection. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin cuts/infections/sores. Some products may make you more sensitive to the sun. Check the label for any warnings or ask your doctor or pharmacist whether you need to take any special precautions when in the sun. Your doctor/pharmacist may suggest that you limit your time in the sun, avoid tanning booths and sunlamps, and use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Some products may stain/discolor clothing. Ask your doctor or pharmacist for more details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding, especially if you are applying this product to the breast area.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, including skin-care products. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: 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: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not use more of this product or use it more often to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze. Store foam at room temperature between 59-77 degrees F (15-25 degrees C). Do not freeze. Store away from heat and open flame. Because the contents of the canister are under pressure, do not puncture or burn the container. Keep all medicines out of reach of children and pets. 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 June 2020. Copyright(c) 2021 First Databank, Inc.