FDA Label for Sodium Sulfacetamide 9 Sulfur 4.5 Wash

Other

In a vehicle containing Green Tea and Aloe

Rx only

All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR:
Acella Pharmaceuticals
Alpharetta, GA 30022
1-800-541-4802

Rev. 0113

Description

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

Chemical Structure - a761feea 86b6 44f0 8f9a 50d29ebb60e9 01

Each gram of Sodium Sulfacetamide 9% - Sulfur 4% Wash contains 90 mg of Sodium Sulfacetamide and 45 mg of Sulfur in a formulation containing: purified water, sodium cocoyl isethionate, magnesium aluminum silicate, disodium oleamido MEA sulfosuccinate, sodium methyl cocoyl taurate, glyceryl stearate (and) PEG-100 stearate, stearyl alcohol, cetyl alcohol, methyl paraben, propyl paraben, butylated hydroxytoluene, xanthan gum, sodium thiosulfate, green tea extract, aloe vera, disodium EDTA, and fragrance.

Clinical Pharmacology

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 not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

Indications & Usage

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

Contraindications

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

Warnings

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.

General Precautions

PRECAUTIONS: 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 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

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

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

Teratogenic Effects

PREGNANCY: Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9% - Sulfur 4.5% Wash. It is not known whether Sodium Sulfacetamide 9% - Sulfur 4% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9% - Sulfur 4.5% Wash should be given to a pregnant woman only if clearly needed.

Nursing Mothers

NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 9% - Sulfur 4.5% Wash. 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 Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is administered to a nursing woman.

Pediatric Use

PEDIATRIC USE: Safety and effectiveness in children under the age of 12 have not been established.

Adverse Reactions

ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.

Dosage & Administration

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 full 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

HOW SUPPLIED: Sodium Sulfacetamide 9% - Sulfur 4.5% Wash is available in 16 oz (454 g) bottles, NDC 42192-144-16.

Storage And Handling

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 MEDICATIONS OUT OF THE REACH OF CHILDREN.

Principal Display Panel - 454 G Bottle Carton

NDC 42192-144-16

Sodium Sulfacetamide 9% -
Sulfur 4.5% Wash
In a vehicle containing
Green Tea and Aloe

Rx only

Net weight 16 oz.

Acella
PHARMACEUTICALS, LLC

PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton - a761feea 86b6 44f0 8f9a 50d29ebb60e9 02