Sodium Sulfacetamide 10% and Sulfur 4%

ROSULA® CLARIFYING WASH is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

ROSULA® CLARIFYING WASH is available in a 16 fl. oz (473 mL) bottle, NDC 10337-667-16.

Store ROSULA® CLARIFYING WASH at controlled room temperature 15°-25°C (59°-77°F).

Protect from freezing.

Manufactured for: Doak Dermatologics, A Subsidiary Of Bradley Pharmaceuticals, Inc., 383 Route 46 West Fairfield, NJ 07004-2402 USA. Manufactured by: Groupe Parima, Inc., Montreal, QC H4S 1X6 CANADA. Issued. 02/07

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep bottle tightly closed.

No information provided.

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.