SODIUM SULFACETAMIDE - SULFUR WASH

Acella Pharmaceuticals

Sodium Sulfacetamide 9% - Sulfur 4% Wash In a vehicle containing Green Tea and Aloe Rx Only

FULL PRESCRIBING INFORMATION

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:

Each mL of Sodium Sulfacetamide 9% - Sulfur 4% Wash contains 90 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a foumrulation containing purified water, sodium cocoyl isethionate, disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and PEG 100 stearate, methyl paraben, propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium EDTA, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl taurate and white petrolatum.Enter section text here

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.

Uses

INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4% 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% Wash is not to be used by patients with kidney disease.

WARNINGS: Although rare, sensitivity to sodium sulfacetaminde 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 - If irritaition 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 withour 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 vulfaris, 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 beenperformed to evaluate carcinogenic potential.

PREGNANCY: Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9% - Sulfur 4% 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% Wash should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 9% - Sulfur 4% Wash. 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 9% - Sulfur 4% Wash is administered to a nursing woman.

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

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

DOSAGE AND ADMINISTRATION: Apply Sodium Sulfacetamide 9% - Sulfur 4% 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% Wash sooner or using less often.

HOW SUPPLIED: Sodium Sulfacetamide 9% - Sulfur 4% Wash is available in 16 ounce bottles,
NDC 42192-121-16.

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

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, LLC
Alpharetta, GA 30009
1-800-541-4802

Sodium Sulfacetamide 9% - Sulfur 4% Wash

In a vehicle containing Green Tea and Aloe

Rx Only

Acella Pharmaceuticals

Net weight 16oz

Indications: for the topical control of acne vulgaris, acne roacea and seborheic dermatitis.

Directions: Apply Sodium Sulfacetamide 9% -Sulfur 4% wash once or twice to affected areas or as directed by a physician. Avoid contact with eyes or mucus membranes. 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 rising off Sodium Sulfacetamide 9% -Sulfur 4% wash sooner or using less often. See package insert for full prescribing information.

Warnings: For external use only. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN. Keep bottle tightly closed.

Contraindications: Sodium Sulfacetamide 9% -Sulfur 4% wash is contraindicated for use in patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation Sodium Sulfacetamide 9% -Sulfur 4% wash is not to be used by patients with kidney disease.

Ingredients: Each mL of Sodium Sulfacetamide 9% -Sulfur 4% wash contains 90 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation containing purified water, sodium cocoyl isethionate, disodium oleamido MEA sulfosuccinate, green tea extract, cetyl alcohol, stearyl alsohol, glycerol stearate and PEG 100 stearate, methyl pareaben, propyl paraben, butylated hydroxytolulene, aloe vera gel, sodium thosulfate, disodium EDTA magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl taurate, white petrolatum.

Store at controlled room termperature 15 - 20 degrees C (59-86degrees F)

Protect from freezing

Sodium Sulfacetamide 9% -Sulfur 4% wash is supplied in a 16 ounce bottle (NDC 42192-121-16). For lot number and expiration date, see bottom of bottle

all prescription substitutions and or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product. No representation is made as to generic status or bioequavalency. Please see package insert for more information.

Manufactured for:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30009

1-800-541-4802