Sodium Sulfacetamide 10%, Sulfur 5%

Generic Name: sodium sulfacetamide 10%, sulfur 5%

Over-the-Counter (OTC)

Brand Names:

Sodium Sulfacetamide, Sulfur

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: Structure

Overview

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: Structure

Uses

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

Dosage

Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and leberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full leather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often. FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPTHALMIC USE. (KEEP AWAY FROM EYES). KEEP OUT OF REACH OF CHILDREN (Shake well before use)

Side Effects

Although rare, sodium sulfacetamide may cause local irritation.

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

Storage

Store at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature. Protect from freezing. In case of accidental ingestion contact a Poison Controll Center immediately. Keep container tightly closed. You may report side effects by calling the FDA at 1-800-FDA-1088

Frequently Asked Questions

What is Sodium Sulfacetamide 10%, Sulfur 5% used for?

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

What are the side effects of Sodium Sulfacetamide 10%, Sulfur 5%?

Although rare, sodium sulfacetamide may cause local irritation.

Can I take Sodium Sulfacetamide 10%, Sulfur 5% during pregnancy?

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

What are the important warnings for Sodium Sulfacetamide 10%, Sulfur 5%?

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. Sodium Sulfacetamide 10% & 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% & Sulfur 5% 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.