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|Rosac Cream

Rosac Cream

Rosac Cream is used for:

Treating acne. It may also be used for other conditions as determined by your doctor.

Rosac Cream is a sulfonamide antibiotic, drying agent, and sunscreen combination. It works by killing bacteria and gently drying the skin to help treat acne. The sunscreen protects the skin from irritation due to sunburn.

Do NOT use Rosac Cream if:

• you are allergic to any ingredient in Rosac Cream
• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rosac Cream:

Some medical conditions may interact with Rosac Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of lupus

Some MEDICINES MAY INTERACT with Rosac Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Silver-containing products (eg, silver sulfadiazine) because the effectiveness of Rosac Cream may be decreased
• Methenamine because the side effects of Rosac Cream may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rosac Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rosac Cream:

Use Rosac Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Rosac Cream is for use on the skin only. Rosac Cream may stain clothing and the skin if too much is used.
• Wash your hands before and immediately after using Rosac Cream. Gently wash the affected area and pat dry. Apply a thin film of medicine to the affected area. Avoid getting Rosac Cream in your eyes, nose, or mouth.
• If you miss a dose of Rosac Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Rosac Cream.

Important safety information:

• It may take several days for Rosac Cream to work fully.
• Avoid getting Rosac Cream in your eyes, nose, or mouth.
• Do not use any other medicines or special cleansers on your skin unless your doctor instructs you otherwise.
• If severe diarrhea, stomach cramps/pain, or bloody stools occur, contact your doctor at once. This could be a symptom of a serious side effect that needs immediate medical attention. Do not treat diarrhea without consulting your doctor.
• Overuse of topical products may worsen your condition.
• Use Rosac Cream with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Rosac Cream during pregnancy. It is unknown if Rosac Cream is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the risks to you baby.

Possible side effects of Rosac Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Irritation, stinging, or burning of the skin.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; fever; joint pain; red, swollen, or blistered skin; severe diarrhea; sores in the mouth; stomach cramps/pain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Rosac Cream may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Store Rosac Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Rosac Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Rosac Cream, please talk with your doctor, pharmacist, or other health care provider.
• Rosac Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rosac Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.