Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam

SSS 10 - 5 Emollient Foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Wash affected areas before use, 1 to 2 times daily as directed by physician. Before each use, shake can vigorously, then gently tap the bottom of the can on a firm surface or in palm of other hand. Tap can 1 - 2 times, then shake and tap again.

Dispense can upright. Depress the actuator and dispense a small amount of foam (not more than a dollop the size of a golf ball). Pointing the can down will cause propellant loss.

Wash affected areas and apply foam 1 or 2 times a day as directed by a physician. Avoid contact with the eyes.

Wash-off Application: Massage the dispensed foam into the affected areas and wait 1 to 2 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 2 times daily, as directed by a physician.

Leave-on Application: Massage the foam into the affected areas 1 to 2 times daily, as directed by a physician. Wipe off anyexcess foam from actuator after use.

Although rare, sodium sulfacetamide may cause local irritation.

Sodium sulfacetamide is a sulfonamide with antibacterial activity. 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 SSS 10 - 5 Emollient Foam contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in an aqueous based emollient foam vehicle containing: Butane, Butylene Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Glycerin, Magnesium Aluminum Silicate, Polysorbate 20, Propane, Titanium Dioxide, Water.

Sodium sulfacetamide exhibits antibacterial activity. 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 para-aminobenzoic 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 is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. Furthermore, in combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibacterium acnes, thereby adding to the product’s antibacterial activity and reducing associated inflammation.

SSS 10 - 5 Emollient Foam is available in a 100 g aluminum can, NDC 42192-143-01. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).

Storage: Store SSS 10 - 5 Emollient Foam between 68° and 77°F (20° and 25°C). Protect from freezing. Store upright.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

Although rare, sensitivity to sodium sulfacetamide may occur. Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. At the first sign of hypersensitivity or skin rash, discontinue use of this preparation. Particular caution should be employed if areas of involved skin to be treated are denuded or abraded.