DailyMed Label: SSS cleanser

DailyMed Label: SSS cleanser

2022

DailyMed Prescription

SSS cleanser

SULFACETAMIDE SODIUM and SULFUR

PruGen Pharmaceuticals

NDC: 42546-174

NDC: 42546-174

NDC: 42546-174

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. Chemical Structure

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.

If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. 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. Long-term studies in animals have not been performed to evaluate carcinogenic potential. Animal reproduction studies have not been conducted with SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%). It is also not known whether SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) should be given to a pregnant woman only if clearly needed. It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%). However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is administered to a nursing woman. Safety and effectiveness in children under the age of 12 has not been established.

Although rare, sodium sulfacetamide may cause local irritation.

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.

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% Rx only Net Wt. 6 oz (170.1g) NDC 42546-174-06 PRINCIPAL DISPLAY PANEL - 170.1 g Tube Carton