Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Dailymed

Rx Only

Description Section

DESCRIPTION

Sodium Sulfacetamide is a sulfonamide with antibacterial 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:



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

Clinical Pharmacology Section

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.

Indications & Usage Section

INDICATIONS

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

Contraindications Section

CONTRAINDICATIONS

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

Warnings Section

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 away from eyes. Keep out of reach of children. Keep container tightly closed.

Precautions

GENERAL PRECAUTIONS SECTION

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 is 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.

INFORMATION FOR PATIENTS SECTION

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 & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis, Mutagenesis and Impairment of Fertility

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

PREGNANCY SECTION

Pregnancy

Category C

Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9% & Sulfur 4.5% Wash. It is also not known whether Sodium Sulfactamide 9% & Sulfur 4.5% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is administered to a nursing woman.

Pediatric Use Section

Pediatric Use

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

Adverse Reactions Section

ADVERSE REACTIONS

Although rare, sodium sulfacetamide may cause local irritation.

Dosage & Administration Section

DOSAGE AND ADMINISTRATION

Apply Sodium Sulfacetamide 9% & Sulfur 4.5% Wash once or twice daily to affected areas or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a lather. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 9% & Sulfur 4.5% Wash sooner or using less often.

How Supplied Section

HOW SUPPLIED

Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is available in a 16 oz (454 g) bottle, NDC 82429-301-21.

Storage And Handling Section

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.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN

Manufactured by:

Gabar Health Sciences, Corp. Atlanta, Georgia 30354

Principal Display Panel - 454 G Bottle Label

NDC 82429-301-21

Rx only

For topical use only

Not ophthalmic use

Sodium Sulfacetamide 9% & Sulfur 4.5% Wash

Gabar Health Sciences Corp.

Net WT. 16oz. (454 g)