Sulfacleanse 8/4 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 mL of SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation consisting of: aloe barbadensis gel, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, glyceryl stearate, green tea extract, magnesium aluminum silicate, methylparaben, PEG-100 stearate, petrolatum, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum.

Sulfacleanse 8/4 - Clinical Pharmacology

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to paraaminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

Indications and Usage for Sulfacleanse 8/4

SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Contraindications

SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is not to be used by patients with kidney disease.

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 away from eyes. Keep out of reach of children. Keep container tightly closed.

Precautions

Adverse Reactions/Side Effects

Although rare, sodium sulfacetamide may cause local irritation.

Sulfacleanse 8/4 Dosage and Administration

Apply SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) sooner or using less often.

How is Sulfacleanse 8/4 supplied

SulfaCleanse® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is available in a 16 fl. oz. (473 mL) bottle, NDC 42546-175-16.

Manufactured for:
PruGen Pharmaceuticals
18899 N Thompson Peak Pkwy
Scottsdale, AZ 85255

Rev.4.0

PRINCIPAL DISPLAY PANEL - 473 ml Bottle Box

NDC 42546-175-16

SulfaCleanse® 8/4
(sodium sulfacetamide 8% & sulfur 4%)

Topical Suspension in a vehicle
containing Green Tea and Aloe

Rx only
16 fl oz (473 ml)

PRUGEN®
PHARMACEUTICALS