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Rosanil Cleanser
  • Professionals
  • FDA PI

Rosanil Cleanser

Generic name:sodium sulfacetamide 10% and sulfur 5%
Dosage form: topical solution
Drug class:Topical antibiotics

Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.

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 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 gram of ROSANIL® (sodium sulfacetamide 10% and sulfur 5%) Cleanser contains: Active: sodium sulfacetamide 10% (100 mg), sulfur 5% (50 mg). Inactive: butylated hydroxytoluene, edetate disodium, emulsifying wax, hydrochloric acid, light mineral oil, methylparaben, PPG-2 hydroxyethyl coco/isostearamide, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate (and) disodium laureth sulfosuccinate, and sodium thiosulfate.

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 form...