Cerisa Wash (sulfacetamide sodium 10 % / sulfur 1 % ) Medicated Liquid Soap

Details

Generic Name: SULFACETAMIDE SODIUM AND SULFUR

Brand Name: Cerisa

Substance Name(s):
SULFUR
SULFACETAMIDE SODIUM

WARNINGS

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 abraded skin are involved.

FOR EXTERNAL USE ONLY.

Keep out of reach of children.

Keep tube tightly closed.

DESCRIPTION

Each gram of CERISA™ WASH contains 100mg of Sodium Sulfacetamide and 10mg of Sulfur in a wash containing Butylated Hydroxytolulene, Cetyl Alcohol, Disodium EDTA, Glyceryl Stearate and PEG-l00 Stearate, Lactic Acid, Magnesium Aluminum Silicate, Methyl Paraben, Propyl Paraben, Purified Water, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Sodium Thiosulfate, Stearyl alcohol, White Petrolatum and Xanthan Gum.

Sodium Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent.

Chemically, Sodium Sulfacetamide is N-{(4-aminophenyl) sulfony}-acetamide, monosodium salt, monohydrate.

The structural formula is: Chemical Structure

HOW SUPPLIED

CERISA™ WASH is available in 170.1g (6.0 oz) tubes,NDC 58980-330-61.

Store at controlled room temperature: 15°-30° C (59°-86° F)

INDICATIONS AND USAGE

CERISA™ WASH is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

PEDIATRIC USE

Pediatric Use Safety and effectiveness in children under the age of 12 have not been established.

PREGNANCY

Pregnancy Category C Animal reproduction studies have not been conducted with CERISA™ WASH.

It is also not known whether CERISA™ WASH can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

CERISA™ WASH should be given to a pregnant woman only if clearly needed.

NUSRING MOTHERS

Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of CERISA™ WASH.

However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk.

In view of this and because many drugs are excreted in human milk, caution should be exercised when CERISA™ WASH is administered to a nursing woman.

DOSAGE AND ADMINISTRATION

Wash affected areas once or twice daily, or as directed by your physician.

Avoid contact with eyes or mucous membranes.

Wet skin and liberally apply to areas to be treated, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.

If dying occurs, it may be controlled by rinsing wash off sooner or using less often.