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This medication is used to treat several skin problems (acne, acne rosacea, seborrheic dermatitis). Sodium sulfacetamide works by stopping the growth of certain bacteria on the skin that can lead to acne and worsen these other skin conditions. It belongs to a class of drugs known as sulfa antibiotics. Sulfur works by helping remove the top layer of dead skin. It belongs to a class of drugs known as keratolytics. It may also help kill acne-causing bacteria and unclog pores.
This medication may also contain other ingredients (for example, other keratolytics such as urea).
How to use Rosula Gel
This medication is for use on the skin only.
Clean and dry the affected skin area and your hands. Some products need to be shaken before use. If so directed on the product label, shake the container well before each use. Apply a thin layer of the product to the areas of skin with acne, rosacea, or seborrhea as directed by your doctor, usually 1 to 3 times daily. Dosage is based on your medical condition and response to treatment. Follow your doctor's directions. Wash your hands with soap and water after each use.
Do not apply this product to skin that is cracked, broken, or raw because this may increase your risk of side effects.
Avoid getting this medication on your eyelids or lips, or in your eyes, nose, or mouth. If you do get medication in these areas, rinse with plenty of water.
Use this medication regularly to get the most benefit from it. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.
Tell your doctor if your condition does not improve after a few weeks. Stop using this medication and tell your doctor right away if your condition worsens, or if you develop a rash or other serious side effects. See Side Effects section.
Mild peeling of the top layer of skin is expected. Skin irritation, redness, and scaling may also occur. If any of these effects persist or worsen, stop using this medication and 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.
Rarely, sodium sulfacetamide products applied to the skin may be absorbed and may cause serious side effects. Stop using this product and tell your doctor right away if any of these rare but serious side effects occur: aching/swollen joints, rash on nose and cheeks, signs of infection (such as fever, persistent sore throat), signs of anemia (such as unusual tiredness/weakness, rapid breathing, fast heartbeat), unusual bleeding/bruising, signs of liver problems (such as dark urine, yellowing eyes/skin, stomach/abdominal pain, persistent nausea, vomiting), mouth sores.
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.List Rosula Gel side effects by likelihood and severity.
Before using this product, tell your doctor or pharmacist if you are allergic to sodium sulfacetamide or sulfur; or to sulfa antibiotics (such as sulfamethoxazole); or to other ingredients listed on the product package; 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: kidney problems.
Tell your doctor if there are areas of skin near where this product will be applied that are cracked, broken, or raw. Injured skin may absorb more of this product, and the chance of serious side effects may increase.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Some products that may interact with this drug include: skin products containing silver (such as silver sulfadiazine).
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
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.
Do not share this medication with others.
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 and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 68-77 degrees F (20-25 degrees C). Protect from freezing. Keep the container cap tightly closed. Keep all medications away from 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 July 2016. Copyright(c) 2016 First Databank, Inc.