Sodium Sulfacetamide 10 Sulfur 5 Cleanser

Stratus Pharmaceuticals
Sonar Products, Inc

SODIUM SULFACETAMIDE 10% & SULFUR 5% CLEANSER

FULL PRESCRIBING INFORMATION: CONTENTS*

• SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER DESCRIPTION
• CLINICAL PHARMACOLOGY
• SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER INDICATIONS AND USAGE
• SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Carcinogenesis, Mutagenesis and Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
  • Pediatric Use
• SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER ADVERSE REACTIONS
• SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label

FULL PRESCRIBING INFORMATION

Rx only

SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER DESCRIPTION

Each gram of SODIUM SULFACETAMIDE 10% and SULFUR 5% CLEANSER contains ACTIVES: sodium sulfacetamide 10% (100mg) and sulfur 5% (50 mg) in a cleanser base of INACTIVES: butylated hydroxytoluene, disodium EDTA, disodium laureth sulfosuccinate and disodium lauryl sulfoacetate, emulsifying wax, hydrochloric acid, methyl paraben, mineral oil, PPG-hydroxyethyl coco isostearamide, propyl paraben, purified water, sodium cocoyl isethionate and sodium thiosulfate

Sodium Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, Sodium Sulfacetamide is N-{(4-aminophenyl)sulfony}-acetamide, monosodium salt, monohydrate.

The structural formula is:

CLINICAL PHARMACOLOGY

The most widely accepted mechanism of action of sulfonamides in 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.

SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER INDICATIONS AND USAGE

SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER CONTRAINDICATIONS

SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER is not to be used by patients with kidney disease.

WARNINGS

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 out of reach of children. Keep bottle tightly closed.

PRECAUTIONS

General

If irritation develops, use of this product should be discontinued and appropriate therapy instituted. Patients should be very carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy i s to achieve desquamation without irritation, but Sodium Sulfacetamide and Sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy

Category C

Animal reproduction studies have not been conducted with SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER. It is also not known whether SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Sodium Sulfacetamide is excreted in human milk following topical use of SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under the age of 12 has not been established.

SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER DOSAGE AND ADMINISTRATION

Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be treated, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing wash off sooner or using less often.

HOW SUPPLIED

SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER is available in:

•  6 oz. (170.3g) bottles - NDC 58980-340-61
•  12 oz. (340.2g) bottles - NDC 58980-340-85

STORAGE

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F), however such exposure should be minimized. Protect from freezing.

Distributed by
STRATUS
PHARMACEUTICALS INC

Manufactured by
Sonar Products, Inc.
Carlstadt, NJ 07072
for
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186-6727

Customer Service
Telephone: 1-800-442-7882
Fax: 305-254-6875

©2011 Stratus Pharmaceuticals Inc.

Rev. SSSC-IN2011-343.

PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label

NDC 58980-340-61

FOR EXTERNAL USE ONLY

SODIUM
SULFACETAMIDE 10%
& SULFUR 5%
CLEANSER

Rx only

STRATUS
PHARMACEUTICALS INC

Net WT. 6 OZ (170.3 g)