Rosaderm Cleanser

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

Medically reviewed by Drugs.com. Last updated on Feb 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 Rosaderm™ (sodium sulfacetamide 10% and sulfur 5%) Cleanser contains:
Active Ingredients: Sodium Sulfacetamide USP 10% (100 mg), Sulfur USP 5% (50 mg).
Inactive Ingredients: Purified Water, Propylene Glycol USP, Cetyl Alcohol NF, Stearyl Alcohol NF, Sodium Magnesium Silicate, Gum Arabic, Sodium Lauryl Sulfate, Phenoxyethanol USP, Benzyl Alcohol NF, Sodium Thiosulfate USP, and Fragrance.

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:

Rosaderm™ Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

Rosaderm™ Cleanser is contraindicated for use by patients havin