Sodium Sulfacetamide and Sulfur

Biocomp Pharma, Inc.

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit

FULL PRESCRIBING INFORMATION: CONTENTS*

• SODIUM SULFACETAMIDE AND SULFUR DESCRIPTION:
• INDICATIONS:
• SODIUM SULFACETAMIDE AND SULFUR CONTRAINDICATIONS:
• CLINICAL PHARMACOLOGY:
• WARNINGS AND PRECAUTIONS:
• SODIUM SULFACETAMIDE AND SULFUR ADVERSE REACTIONS:
• SODIUM SULFACETAMIDE AND SULFUR DOSAGE AND ADMINISTRATION:
• HOW SUPPLIED:

FULL PRESCRIBING INFORMATION

DESCRIPTION:

Each mL of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation of: aloe vera, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, fragrance, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol and xanthan gum.

Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C₈H₉N₂NaO₃S·H₂O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:

INDICATIONS:

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur, or any other component of this preparation. This drug is not to be used by patients with kidney disease.

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.

WARNINGS AND PRECAUTIONS:

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes.

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this product 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.

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

Information for Patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product 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 this product. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

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

ADVERSE REACTIONS:

Although rare, sodium sulfacetamide may cause local irritation. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-866-762-2365.

DOSAGE AND ADMINISTRATION:

Wash affected areas once or twice daily, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.

HOW SUPPLIED:

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash is supplied in a 16 oz (454 g) bottle, NDC 44523-605-16.

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. Keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN.

Manufactured for:

BIOCOMP PHARMA^®, INC.

San Antonio, TX 78230 1355

C01 Rev 012120