Sodium Sulfacetamide

in a Urea Vehicle

FOR DERMATOLOGIC USE ONLY

Rx only

NOT FOR OPHTHALMIC USE

Sodium Sulfacetamide Medicated Pads 10% contain a 10% solution of sodium sulfacetamide on a textured pad. Each gram of medicated solution contains 100 mg sodium sulfacetamide, purified water, sodium EDTA, sodium thiosulfate and urea ( 1 0%). Sodium Sulfacetamide Medicated Pads are greaseless and leave no residue when applied to the skin.

Sodium sulfacetamide is a sulfonamide with antibacterial activity. Chemically, sodium sulfacetamide is C₈H₉N₂Na0₃S•H₂O, with a molecular weight of 254.24. Chemically it is acetamide, N- [(4 aminophenyl) sulfonyl]-, monosodium salt and monohydrate, with the following structural formula:

Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide-sensitive gram-positive and gram-negative micro-organism including P. acne commonly isolasted from secondary cutaneous pyogenic infections.

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 P ( ABA), an essential component for bacterial growth. While absorption through intact skin in humans 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 o t 12.8 hours.

Sodium Sulfacetamide Medicated Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Sodium Sulfacetamide Medicated Pads are contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the preparation. Sodium Sulfacetamide Medicated Pads are not to be used by patients with kidney disease.

Although rare, sensitivity t o 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. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported.

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Patients should discontinue the use of Sodium Sulfacetamide Medicated Pads if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Sodium Sulfacetamide Medicated Pads also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.

Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity, which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome has been reported (see WARNINGS).

Gently apply Sodium Sulfacetamide Medicated Pads to the affected areas 1 to 2 times daily or as directed by a physician until the infection has cleared.

Sodium Sulfacetamide Medicated Pads NDC 0168-0484-01 contain 30 Foil Pouches, each with a single-use medicated pad (2.5 mL each).

Store at 15°-30° C (59°-86° F). Protect from freezing.

Sodium Sulfacetamide Medicated Pads may darken after prolonged storage. Slight discoloration does not impair the efficacy or safety of the product.

Manufactured for: E. FOUGERA & CO.
A division of Nycomed US Inc., Melville New York 11747
Manufactured by: Pegasus Laboratories, Inc., Pensacola, FL 32514

IL302A R3/09

NDC 0168-0484-01

30 Foil Pouches (2.5 mL each)

Fougera^®

SODIUM SULFACETAMIDE

Medicated Pads 10%

In a Urea Vehicle

For Topical Use Only

For dermatologic use only – not for ophthalmic use

Contains: 30 Foil Pouches, each with a single-use medicated pad (2.5 mL each)

Rx only

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

NDC 0168-0484-01

2.5 mL

Fougera^®

SODIUM SULFACETAMIDE

Medicated Pads 10%

in a Urea Vehicle

For Topical Use Only

For dermatologic use only – not for ophthalmic use

Single-use medicated pad 2.5 mL

Rx only

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747