Avar Cleanser, Avar Gel, Avar Green, Avar-e Green Cream, Avar-e Emollient Cream (Sirius)

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FOR DERMATOLOGICAL USE ONLY

NOT FOR OPHTHALMIC USE

DESCRIPTION

Each gram of AVAR™ Gel (sodium sulfacetamide 10% and sulfur 5%) contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in an aqueous based emollient gel vehicle containing purified water USP, sodium magnesium silicate, emulsifying lipids, nicotinamide, disodium EDTA, sodium thiosulfate, zinc oxide, benzyl alcohol, phenoxyethanol, glycerin, xanthan gum, sodium lactate, polyacrylamide, C13-C14 isoparaffin, laureth-7, fragrance.

Each gram of AVAR™ Green (sodium sulfacetamide 10% and sulfur 5%) Color Corrective Gel contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in an aqueous based emollient gel vehicle containing purified water USP, sodium magnesium silicate, emulsifying lipids, nicotinamide, disodium EDTA, sodium thiosulfate, zinc oxide, benzyl alcohol, phenoxyethanol, glycerin, xanthan gum, sodium lactate, polyacrylamide, C13-C14 isoparaffin,laureth-7, fragrance, chromium oxide green.

Each gram of AVAR™ Cleanser (sodium sulfacetamide 10% and sulfur 5%) contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in a mild aqueous based cleansing vehicle containing purified water USP, sodium magnesium silicate, sodium thiosulfate, propylene glycol, sodium lauryl sulfate, cetyl alcohol, stearyl alcohol, phenoxyethanol, fragrance.

Each gram of AVAR™- e Emollient Cream (sodium sulfacetamide 10% and sulfur 5%) contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in an emollient cream vehicle containing purified water, isostearyl palmitate, glyceryl stearate and PEG-100 stearate, sodium lactate USP, glycerin USP, self-emulsifying wax NF, zinc oxide USP, benzyl alcohol NF, nicotinamide, cetyl alcohol NF, dimethicone, sodium thiosulfate, phenoxyethanol, disodium EDTA, fragrance.

Each gram of AVAR™- e Green Cream (sodium sulfacetamide 10% and sulfur 5%) color corrective emollient cream contains 100 mg of sodium sulfacetamide and 50 mg of colloidal sulfur in an emollient cream vehicle containing purified water, isostearyl palmitate, glyceryl stearate and PEG-100 stearate, sodium lactate USP, glycerin USP, self-emulsifying wax NF, zinc oxide USP, benzyl alcohol NF, chromium oxide green, nicotinamide, cetyl alcohol NF, dimethicone, sodium thiosulfate, phenoxyethanol, disodium EDTA, fragrance.

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:

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.

INDICATIONS

AVAR Gel, AVAR Green, AVAR Cleanser, AVAR- e Emollient Cream and AVAR- e Green Cream are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS

AVAR Gel, AVAR Green, AVAR Cleanser, AVAR- e Emollient Cream and AVAR- e Green Cream are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of these preparations. AVAR Gel, AVAR Green, AVAR Cleanser, AVAR- e Emollient Cream, and AVAR- e Green Cream are 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 away from eyes. Keep out of the reach of children. Keep containers tightly closed.

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 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 AVAR Gel, AVAR Green, AVAR Cleanser, AVAR- e Emollient Cream, or AVAR- e Green Cream. It is also not known whether AVAR Gel, AVAR Green, AVAR Cleanser, AVAR- e Emollient Cream, or AVAR- e Green Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AVAR Gel, AVAR Green, AVAR Cleanser, AVAR- e Emollient Cream, and AVAR- e Green Cream 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 AVAR Gel, AVAR Green, AVAR Cleanser, AVAR- e Emollient Cream, or AVAR- e Green Cream. 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 AVAR Gel, AVAR Green, AVAR Cleanser, AVAR- e Emollient Cream, or AVAR- e Green Cream are 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

AVAR Gel:   Apply a thin film of AVAR Gel to affected areas 1 to 3 times daily, or as directed by a physician.

AVAR Green Color Corrective Gel:   Apply a thin layer of AVAR Green to affected areas 1 to 3 times daily, or as directed by a physician. Apply only a small amount of AVAR Green to affected area and massage the green gel completely and uniformly into the skin.

AVAR Cleanser:   Wash affected areas with AVAR Cleanser 1 to 2 times daily, or as directed by a physician. Avoid contact with eyes or mucous 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 rinsing cleanser off sooner or using cleanser less often.

AVAR- e Emollient Cream:   Apply a thin film of AVAR- e Emollient Cream to affected areas 1 to 3 times daily, or as directed by a physician.

AVAR- e Green Cream:   Apply a thin layer of AVAR- e Green Cream to affected areas 1 to 3 times daily, or as directed by a physician. Apply only a small amount of AVAR- e Green Cream to affected area and massage the green cream completely and uniformly into the skin.

HOW SUPPLIED

AVAR Gel - 45 g tubes (NDC 65880-001-45).

AVAR Green Color Corrective Gel - 45 g tubes (NDC 65880-002-45).

AVAR Cleanser - 8 oz. (226.8 g) bottles with a pump dispenser (NDC 65880-200-08)

AVAR- e Emollient Cream - 45 g tubes (NDC 65880-400-45)

AVAR- e Green Cream - 45 g tubes (NDC 65880-402-45)

Store between 15° and 25°C (59° and 77°F). Do not freeze.

Manufactured for:

Sirius Laboratories, Inc.

Vernon Hills, IL 60061

By: Harmony Laboratories Inc.

Landis, NC 28088

Patent Pending AVAR™ Gel, AVAR™ Green, AVAR™ Cleanser and AVAR™- e Green Cream

45011 0103 75151 1203

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