Rosanil

DRUG DESCRIPTION

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acet-amide, monosodium salt, monohydrate. The structural formula is:

Sodium sulfacetamide structural formula illustration

Each gram of ROSANIL® (sodium sulfacetamide 10% and sulfur 5%) Cleanser contains: Active: sodium sulfacetamide 10% (100 mg), sulfur 5% (50 mg). Inactive: butylated hydroxytoluene, ede-tate disodium, emulsifying wax, hydrochloric acid, light mineral oil, methylparaben, PPG-2 hydroxyethyl coco/isostearamide, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate (and) disodium laureth sulfosuccinate, and sodium thiosulfate.

What are the possible side effects of sodium sulfacetamide-sulfur topical?

Serious side effects are not likely to occur with the use of sodium sulfacetamide-sulfur topical. Stop using sodium sulfacetamide-sulfur topical and seek emergency medical attention or contact your doctor immediately if you experience

  • an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives);
  • new or worsening signs of a skin rash;
  • soreness of the joints;
  • fever; or
  • sores in the mouth.

More commonly, you...

Read All Potential Side Effects and See Pictures of Rosanil »

What are the precautions when taking sodium sulfacetamide and sulfur (Rosanil)?

Before using sulfacetamide with sulfur, tell your doctor or pharmacist if you are allergic to it; or to other products containing sulfa or sulfur; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Based on information of related drugs, this medication may pass into breast milk. Consult your doctor before breast-...

Read All Potential Precautions of Rosanil »


Rosanil Consumer (continued)

SIDE EFFECTS: Redness, irritation or scaling of the skin may occur. If any of these effects persist or worsen, notify your doctor 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 immediately if any of these serious side effects occur: cracked skin.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual weakness/fatigue, dark urine, yellowing eyes or skin, other signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

You may be at increased risk for side effects if this medication is used on raw or broken skin. Consult your doctor for details.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), 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.

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 sulfacetamide with sulfur, tell your doctor or pharmacist if you are allergic to it; or to other products containing sulfa or sulfur; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Based on information of related drugs, this medication may pass into breast milk. Consult your doctor before breast- feeding.


Rosanil Patient Information Including Side Effects

Brand Names: Novacet, Plexion, Plexion SCT, Plexion TS, Rosanil Cleanser, Rosula, Rosula Cleanser, Sulfacet-R, Zetacet Wash

Generic Name: sodium sulfacetamide-sulfur topical (Pronunciation: SO dee um sull fah SEH tah mide-SULL fer TAH pih kal)

  • What is sodium sulfacetamide-sulfur topical (Rosanil)?
  • What are the possible side effects of sodium sulfacetamide-sulfur topical?
  • What is the most important information I should know about sodium sulfacetamide-sulfur topical?
  • What should I discuss with my healthcare provider before using sodium sulfacetamide-sulfur topical?
  • How should I use sodium sulfacetamide-sulfur topical?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using sodium sulfacetamide-sulfur topical?
  • What other drugs will affect sodium sulfacetamide-sulfur topical?
  • Where can I get more information?

What is sodium sulfacetamide-sulfur topical (Rosanil)?

Sodium sulfacetamide is an antibacterial agent. Sodium sulfacetamide interferes with the growth of bacteria on the skin. Sulfur may also inhibit the growth of bacteria on the skin and it may cause drying of the skin.

Sodium sulfacetamide-sulfur topical is used in the treatment of acne, rosacea, and seborrheic dermatitis (a red, flaking skin rash).

Sodium sulfacetamide-sulfur topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of sodium sulfacetamide-sulfur topical?

Serious side effects are not likely to occur with the use of sodium sulfacetamide-sulfur topical. Stop using sodium sulfacetamide-sulfur topical and seek emergency medical attention or contact your doctor immediately if you experience

  • an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives);
  • new or worsening signs of a skin rash;
  • soreness of the joints;
  • fever; or
  • sores in the mouth.

More commonly, you may experience some redness, warmth, swelling, itching, stinging, burning, or irritation of the treated area. If these side effects are excessive, notify your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sodium sulfacetamide-sulfur topical?

Stop using sodium sulfacetamide-sulfur topical and contact your healthcare provider if you develop new or worsening signs of a skin rash, soreness of the joints, fever, or sores in the mouth.

Do not use other topical products on the same area unless otherwise directed by your doctor. They may interfere with the effects or absorption of sodium sulfacetamide-sulfur topical.

Do not cover the area after applying sodium sulfacetamide-sulfur topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

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