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Sulfatol 10-4 Cleansing Pads
  • Professionals
  • FDA PI

Sulfatol 10-4 Cleansing Pads

Generic name:sulfacetamide sodium and sulfur
Dosage form: cloth
Drug class:Topical antibiotics

Medically reviewed by Drugs.com. Last updated on Dec 22, 2021.

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.

DESCRIPTION: Sodium sulfacetamide is a sulfacetamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.

Each pad of SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads is coated with a cleanser-based formulation contains 100mg of Sodium Sulfacetamide and 40mg of Sulfur. The cleanser base consists of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl steartate/PEG-100 stearate, green tea, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate, stearyl alcohol.

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 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.

INDICATIONS:SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Sulfatol