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Virti-Sulf Cream

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. For further information about unapproved drugs, click here.

VIRTI-SULF
(sodium sulfacetamide 10% and sulfur 5%)
Emollient Cream

Rx only

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.

INDICATIONS

VIRTI-SULF (sodium sulfacetamide 10% and sulfur 5%) Emollient Cream is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

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.

Warnings

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.

Precautions

General

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.

Pregnancy

Pregnancy 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.

Nursing Mothers

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.

Pediatric Use

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

Adverse Reactions

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.

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619

Revised July 2012

PRINCIPAL DISPLAY PANEL - 28g Tube Carton

VIRTUS
PHARMACEUTICALS

NDC 76439-321-01
Virti-Sulf
Emollient Cream

(sodium sulfacetamide 10%
and sulfur 5%)

Rx only
1 oz
(28 g)

VIRTI-SULF 
sulfacetamide sodium and sulfur cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76439-321
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g
SULFUR (SULFUR) SULFUR 50 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Glycerin  
BUTYLATED HYDROXYTOLUENE  
Cetyl Alcohol  
Edetate Disodium  
Glyceryl Monostearate  
ISOSTEARYL PALMITATE  
PEG-100 STEARATE  
Methylparaben  
Propylene Glycol  
Propylparaben  
Sodium Thiosulfate  
Water  
Xanthan Gum  
Packaging
# Item Code Package Description
1 NDC:76439-321-01 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/12/2012
Labeler - Virtus Pharmaceuticals (969483143)
Revised: 09/2012
 
Virtus Pharmaceuticals
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