Sodium Sulfacetamide 10 Sulfur 2 Cleanser

Sodium Sulfacetamide 10 Sulfur 2 Cleanser is an FDA-registered drug product whose active ingredient is SULFACETAMIDE SODIUM AND SULFUR. It is labelled by Acella Pharmaceuticals, LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 42192-147, label effective 20260713. It is one of 4 FDA drug label records sharing the active ingredient SULFACETAMIDE SODIUM AND SULFUR. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SULFACETAMIDE SODIUM AND SULFUR are most often described in connection with: indications sodium, sulfacetamide sulfur, cleanser indicated, topical control, acne vulgaris, seborrheic dermatitis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS: SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

DOSAGE AND ADMINISTRATION: Wash affected areas with SODIUM SULFACETAMIDE 10% - SULFUR 2% 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 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.

CONTRAINDICATIONS: SODIUM SULFACETAMIDE 10% - 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% - SULFUR 2% CLEANSER is 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. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF REACH OF CHILDREN.

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

FDA lists 4 drug label records with SULFACETAMIDE SODIUM AND SULFUR as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Sodium Sulfacetamide 10 Sulfur 2 Cleanser used for?
INDICATIONS: SODIUM SULFACETAMIDE 10% - SULFUR 2% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Who makes Sodium Sulfacetamide 10 Sulfur 2 Cleanser?
Acella Pharmaceuticals, LLC is the labeler of record for Sodium Sulfacetamide 10 Sulfur 2 Cleanser. 4 FDA label records share the active ingredient SULFACETAMIDE SODIUM AND SULFUR, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Sodium Sulfacetamide 10 Sulfur 2 Cleanser come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Sodium Sulfacetamide 10 Sulfur 2 Cleanser prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SULFACETAMIDE SODIUM AND SULFUR?
Yes. 4 FDA drug label records list SULFACETAMIDE SODIUM AND SULFUR as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Sodium Sulfacetamide 10 Sulfur 2 Cleanser been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.