Generic Name: sulfacetamide sodium and sulfur
Dosage Form: cream
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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Virti-Sulf Cream Description
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]- acetamide, monosodium salt, monohydrate.
The Structural formula is:
Each gram of VIRTI-SULF (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream contains 100mg of Sodium Sulfacetamide and 50 mg of Sulfur in a base containing BHT, Cetyl Alcohol, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate, Isostearyl Palmitate, PEG-100 Stearate, Methylparaben, Propylene Glycol, Propylparaben, Sodium Thiosulfate, Water, Xanthan Gum.
Virti-Sulf Cream - Clinical Pharmacology
Sodium sulfacetamide exhibits antibacterial activity. It is believed to block bacterial growth by acting as a competitive antagonist of para-aminobenzoic acid (PABA). While absorption through intact skin has not been determined for sodium sulfacetamide, it is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of the keratolytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit P. acnes, thereby reducing the associated inflammation.
VIRTI-SULF (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
VIRTI-SULF Emollient Cream are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of these preparations. VIRTI-SULF Emollient Cream is not to be used by patients with kidney disease.
Although rare, hypersensitivity reactions to products containing sodium sulfacetamide may occur, including Stevens- Johnson syndrome and exfoliative dermatitis. 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 away from eyes. Keep out of reach of children.
Although the object of this therapy is to achieve desquamation without irritation, this product poses a low potential for irritation, which may include reddening and scaling of the epidermis. Uncommon adverse reactions such as dryness, erythema, itching and edema may occur. Therefore, patients should be monitored for possible local irritation or sensitization. Use of the product should be discontinued if excessive irritation develops.
Information for Patients
Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PregnancyPregnancy Category C
Animal reproduction studies have not been conducted with VIRTI-SULF (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream. It is not known whether VIRTI-SULF Emollient Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VIRTI-SULF Emollient Cream should be used during pregnancy only if the potential benefit outweighs the potential risk.
It is not known whether sodium sulfacetamide is excreted in human milk following topical use of VIRTI-SULF Emollient Cream. However, small amounts of orally administered sulfonamides have been detected in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when VIRTI-SULF Emollient Cream is administered to a nursing woman.
Safety and effectiveness in children under the age of 12 have not been established.
Although rare, adverse reactions such as dryness, erythema, itching and edema have been reported.
Virti-Sulf Cream Dosage and Administration
VIRTI-SULF Emollient Cream
Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily, or as directed by a physician. To minimize potential dryness, start with one application daily, and then gradually increase to 2-3 times daily as needed or as directed by a physician.
How is Virti-Sulf Cream Supplied
VIRTI-SULF (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream is available in 1 oz (28 g) tubes (NDC 76439-321-01).
Store at 15-25°C (59-77°F). Avoid excessive heat.
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
Revised July 2012
PRINCIPAL DISPLAY PANEL - 28g Tube Carton
(sodium sulfacetamide 10%
and sulfur 5%)
1 oz (28 g)
sulfacetamide sodium and sulfur cream
|Labeler - Virtus Pharmaceuticals (969483143)|
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- Drug class: topical antibiotics