Sodium Sulfacetamide and Sulfur Foam

Sodium sulfacetamide exhibits antibacterial activity. 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.

It is estimated that 1% of topically applied sulfur is absorbed. Although the exact mode of keratolytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfur has been reported to inhibit the growth of Propionibacterium acnes thereby reducing the associated inflammation.

Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Prime Can Before Initial Use:
Shake can well (until product moves inside can). Firmly strike bottom of can onto palm of hand at least three times.

Hold can upright and direct initial spray to a non-skin surface. Until foam dispenses, DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, repeat priming process.

WASH-OFF APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Dispense product onto fingertips. Massage the dispensed foam into the affected area and wait 10 minutes. Rinse thoroughly with water and pat dry. Treat the affected area 1 to 3 times daily, or as directed by a physician.

LEAVE-ON APPLICATION: Cleanse affected skin thoroughly and pat dry before each application. Dispense product onto fingertips. Massage the dispensed foam into the affected area 1 to 3 times daily or as directed by a physician.

Wipe off any excess foam from actuator after use.

Sodium Sulfacetamide 10% and Sulfur 5% Emollient Foam is supplied in a 60g (NDC 49808-154-60) aluminum can.

Store between 59° and 86°F (15° and 30°C). Protect from freezing. Store upright.

Manufactured For:

Metacon Labs
Cumberland, RI 02864
866-777-4633
www.metaconlabs.com

Patent Pending
P/N 2617 Rev. 1

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY - Metacon Can

Rx Only

Sodium Sulfacetamide 10%

and Sulfur 5%

Emollient Foam

NDC 49808-154-60

Net Weight 60g