Sulfatol Gel

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

Medically reviewed by Drugs.com. Last updated on Nov 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.

Rx Only

Sulfatol Gel Description

Sodium sulfacetamide is a sulfonamide with antibacterial activity. 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 Sulfatol™ Gel (Sodium Sulfacetamide 10%, and Sulfur 5% in a Urea vehicle) contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in an emulsion base containing Urea 10%, Benzyl Alcohol, Cetyl Alcohol, Cocoglycerides, Dimethicone, Disodium EDTA, Fragrance, Glyceryl and PEG-100 Stearate, Isopropyl Myristate, Light Mineral Oil, Polysorbate 60, Propylene Glycol, Sodium Thiosulfate, Sorbitan Monostearate, Stearyl Alcohol, Purified Water, Xanthan Gum, and Zinc Ricinoleate.

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

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

Contraindications

Sulfatol™ Gel