Carmol Scalp Treatment Kit

You should not use this medication if you are allergic to sulfacetamide, urea, or sulfa drugs. Do not use sulfacetamide sodium and urea topical medicated pads if you have kidney disease.

To make sure you can safely use sulfacetamide sodium and urea topical, tell your doctor if you have a history of burns, open sores, or skin wounds in the skin area you plan to treat with this medication.

Do not use sulfacetamide sodium and urea topical to treat any skin condition that has not been checked by your doctor.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve, or if they get worse while using sulfacetamide sodium and urea topical.

Do not share this medication with another person, even if they have the same symptoms you have.

You should not use this medication if you are allergic to sulfacetamide, urea, or sulfa drugs. Do not use sulfacetamide sodium and urea topical medicated pads if you have kidney disease.

To make sure you can safely use sulfacetamide sodium and urea topical, tell your doctor if you have a history of burns, open sores, or skin wounds in the skin area you plan to treat with this medication.

Do not use sulfacetamide sodium and urea topical to treat any skin condition that has not been checked by your doctor.

FDA pregnancy category C. It is not known whether sulfacetamide sodium and urea topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether sulfacetamide sodium and urea topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. Do not apply the medication to your lips or eyelids. Do not use sulfacetamide sodium and urea topical on irritated or broken skin.

Avoid using other medications on the areas you treat with sulfacetamide sodium and urea topical unless your doctor tells you to.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sulfacetamide sodium and urea topical and call your doctor at once if you have a serious side effect such as:

• fever, sore throat, body aches, flu symptoms;

• mouth sores;

• easy bruising or bleeding, unusual weakness;

• dark urine, jaundice (yellowing of the skin or eyes); or

• warmth, swelling, oozing, or other signs of skin infection; or

• severe burning, stinging, swelling, or redness of your skin after applying this medicine.

Less serious side effects may include mild skin irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to sulfacetamide sodium / urea topical: topical lotion, topical pad

Hypersensitivity

Hypersensitivity side effects, including irritation, have been reported rarely.

Hypersensitivity side effects associated with sulfonamides, including topical sulfonamides, have included Stevens-Johnson syndrome and toxic epidermal necrolysis. A case of local hypersensitivity which progressed to a fatal syndrome resembling systemic lupus erythematosus has also been reported. Sensitization may recur upon reexposure to sulfonamides by different routes of administration.[Ref]

Hematologic

Hematologic side effects associated with sulfonamides have included agranulocytosis, aplastic anemia, and other blood dyscrasias.[Ref]

Hepatic

Hepatic side effects associated with sulfonamides have included fulminant hepatic necrosis.[Ref]

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