Sodium Sulfacetamide 10% And Sulfur 5% Cleanser

Apply Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 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 10% and Sulfur 5% Cleanser sooner or using less often.

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is not to be used by patients with kidney disease.

Although rare, sodium sulfacetamide may cause local irritation.

Call your doctor for medical advice about side effects. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is available in 6 oz. (170.3 g) bottles, NDC 69367-247-06, 8 oz. (227 g), NDC 69367-247-08, and 12 oz. (340.2 g) bottles, NDC 69367-247-12.

Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a formulation containing Aloe Vera Leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.

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:

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

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.

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. In case of accidental ingestion contact a poison control center immediately. Keep container tightly closed.

Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 5% Cleanser. It is also not known whether Sodium Sulfacetamide 10% and Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

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

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser. 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 10% and Sulfur 5% Cleanser is administered to a nursing woman.

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 known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

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.

NDC 69367-247-06

Rx Only

Sodium

Sulfacetamide 10%

and Sulfur 5%

Cleanser

FOR EXTERNAL USE ONLY

6 oz (170.3 g)

Westminster

Pharmaceuticals

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

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

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.

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. In case of accidental ingestion contact a poison control center immediately. Keep container tightly closed.

Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% and Sulfur 5% Cleanser. It is also not known whether Sodium Sulfacetamide 10% and Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.

Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a formulation containing Aloe Vera Leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.

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:

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is available in 6 oz. (170.3 g) bottles, NDC 69367-247-06, 8 oz. (227 g), NDC 69367-247-08, and 12 oz. (340.2 g) bottles, NDC 69367-247-12.

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

It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser. 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 10% and Sulfur 5% Cleanser is administered to a nursing woman.

Although rare, sodium sulfacetamide may cause local irritation.

Call your doctor for medical advice about side effects. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is not to be used by patients with kidney disease.

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 known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

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.

Apply Sodium Sulfacetamide 10% and Sulfur 5% Cleanser 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 10% and Sulfur 5% Cleanser sooner or using less often.

NDC 69367-247-06

Rx Only

Sodium

Sulfacetamide 10%

and Sulfur 5%

Cleanser

FOR EXTERNAL USE ONLY

6 oz (170.3 g)

Westminster

Pharmaceuticals

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