Sodium Sulfacetamide 9.8% Sulfur 4.8%

Generic Name: sodium sulfacetamide 9.8% sulfur 4.8%

Over-the-Counter (OTC)

Brand Names:

Sodium Sulfacetamide 9.8% Sulfur 4.8% Cleanser

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.

Overview

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.

Uses

INDICATIONS Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage

DOSAGE AND ADMINISTRATION Wash affected area once or twice daily, or as directed by your 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 less often.

Side Effects

ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.

Warnings

WARNINGS Although it is 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. CONTRAINDICATIONS Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is not to be used by patients with kidney disease.

Pregnancy

PREGNANCY Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser. It is also not known whether Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser should be given to a pregnant woman only if clearly needed.

Storage

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.

Frequently Asked Questions

What is Sodium Sulfacetamide 9.8% Sulfur 4.8% used for?

INDICATIONS Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

What are the side effects of Sodium Sulfacetamide 9.8% Sulfur 4.8%?

ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.

Can I take Sodium Sulfacetamide 9.8% Sulfur 4.8% during pregnancy?

PREGNANCY Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser. It is also not known whether Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser should be given to a pregnant woman only if clearly needed.

What are the important warnings for Sodium Sulfacetamide 9.8% Sulfur 4.8%?

WARNINGS Although it is 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. CONTRAINDICATIONS Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is not to be used by patients with kidney disease.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.