Hydrocortisone Acetate, Urea Topical cream
What is this medicine?
HYDROCORTISONE; UREA (hye droe KOR ti sone; yoo REE uh) is a combination of a corticosteroid and a moisturizer. It is used on the skin to reduce swelling, redness, itching, and skin irritation.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
large areas of burned or damaged skin
skin wasting or thinning
an unusual or allergic reaction to hydrocortisone, urea, sulfites, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is for external use only. Do not take by mouth. Follow the directions on the prescription label. Wash your hands before and after use. Do not cover with a bandage or dressing unless your doctor or health care professional tells you to. Use your medicine at regular intervals. Do not use it more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. Do not use this medicine for diaper rash unless directed to do so by your doctor. If applying this medicine to the diaper area, do not cover with tight-fitting diapers or plastic pants. This may increase the amount of medicine that passes through the skin and increase the risk of serious side effects.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
Interactions are not expected. Do not use any other skin products on the same area of skin without asking your doctor or health care professional.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.
Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water.
This medicine can make certain skin conditions worse. Only use it for conditions for which your doctor or health care professional has prescribed.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
burning feeling on the skin
dark red spots on the skin
lack of healing of skin condition
painful, red, pus filled blisters in hair follicles
thinning of the skin
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
dry skin, irritation
unusual increased growth of hair on the face or body
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Keep tightly closed. Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert