SSS cleanser
(SULFACETAMIDE SODIUM and SULFUR)SSS cleanser Prescribing Information
SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Apply SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) 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 SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) sooner or using less often.
SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is not to be used by patients with kidney disease.
Although rare, sodium sulfacetamide may cause local irritation.
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 SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) contains 100 mg of Sulfacetamide Sodium, USP and 10 mg of Sulfur in a formulation consisting of: Aloe Barbadensis Leaf Juice, Butylated Hydroxy Toluene, Camellia Sinensis Leaf Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Glyceryl Stearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylene Glycol, Propylparaben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, White Petrolatum, Xanthan Gum.
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 has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is available in a 6 oz. (170.1g) tube, NDC 42546-174-06.
Store at 20°C to 25°C (68°F to 77°F)
Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.