Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

INDICATIONS: Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

+ 3 more

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Anticoagulation Therapy for Stroke Prevention

Anticoagulation Therapy for Stroke Prevention

Anticoagulation therapy for Stroke Prevention Learning Zone offers a deep-dive into atrial fibrillation causes, consequences, diagnosis and management to help you deliver optimal care and prevent strokes in patients living with this common arrhythmia.

Load more

Related Content

Advisory information

contraindications
CONTRAINDICATIONS: Sodium Sulfacetamide 10% and Sulfur 2% 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 2% Cleanser is not to be used by patients with kidney disease.
Special warnings and precautions
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 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 the 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 Sodium Sulfacetamide 10% and Sulfur 2% Cleanser. It is also not known whether Sodium Sulfacetamide 10% and Sulfur 2% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 2% Cleanser should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in human milk following topical use of Sodium Sulfacetamide 10% and Sulfur 2% Cleanser. However, small amounts of orally administered sulfonamides have been reported to be excreted 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 2% Cleanser is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 has not been established.
Adverse reactions
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Wash affected areas with Sodium Sulfacetamide 10% and Sulfur 2% Cleanser one to two times 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 to 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.

More information

Category Value
Agency product number 70FD1KFU70
Orphan designation No
Product NDC 70156-108
Date Last Revised 06-02-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1000895
Marketing authorisation holder Noble Pharmaceuticals, LLC