Topisulf Cream

Apply Topisulf Emollient Cream to affected areas 1-3 times daily, or as directed by your doctor. First, cleanse your skin thoroughly before application. Second, apply a thin layer of Topisulf Emollient Cream to the affected areas as directed by your doctor. Finally, start using Topisulf Emollient Cream once daily to minimize dryness, then increase application frequency to 2-3 times daily or as directed by your doctor.

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraided skin are involved. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. In addition, patients with kidney disease should not use Topisulf Emollient Cream.

Topisulf Emollient Cream is for external use only. Avoid contact with the eyes, eyelids, lips, other mucous membranes and any damaged areas of the skin, such as wounds or open sores. If accidental contact with one of these areas occurs, rinse thoroughly with water.

Keep out of the reach of children.

Like any medication, Topisulf Emollient Cream may occasionally cause side effects in some people. Although uncommon, some possible side effects may include skin irritation such as redness, dryness, itching or swelling. If you experience excessive skin irritation, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry skin.
• Itching.
• Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Topisulf may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.