SODIUM SULFACETAMIDE - SULFUR WASH
SODIUM SULFACETAMIDE - SULFUR WASH is an FDA drug label for the active ingredient SODIUM SULFACETAMIDE, SULFUR manufactured by ACELLA PHARMACEUTICALS administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260714.
- Generic name
- SODIUM SULFACETAMIDE, SULFUR
- Manufacturer
- ACELLA PHARMACEUTICALS
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 42192-121
- Application
- N/A
- Label effective
- 20260714
About this product
SODIUM SULFACETAMIDE - SULFUR WASH is an FDA-registered drug product whose active ingredient is SODIUM SULFACETAMIDE, SULFUR. It is labelled by ACELLA PHARMACEUTICALS taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 42192-121, label effective 20260714. It is one of 5 FDA drug label records sharing the active ingredient SODIUM SULFACETAMIDE, 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.
What it is used for
Across FDA labelling, products containing SODIUM SULFACETAMIDE, SULFUR are most often described in connection with: indications sodium, sulfacetamide sulfur, wash 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 & Usage
INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Apply Sodium Sulfacetamide 9% - Sulfur 4% Wash 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 9% - Sulfur 4% Wash sooner or using less often.
Contraindications
CONTRAINDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. Sodium Sulfacetamide 9% - Sulfur 4% Wash is not to be used by patients with kidney disease.
Warnings
WARNINGS: Although rare, sensitivity to sodium sulfacetaminde 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. Keep container tightly closed.
Adverse Reactions
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.
More products with the same ingredient
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE, SULFUR
View labelSODIUM SULFACETAMIDE, SULFUR
View labelSODIUM SULFACETAMIDE, SULFUR
View labelSODIUM SULFACETAMIDE, SULFUR
View labelHow products containing SODIUM SULFACETAMIDE, SULFUR compare
FDA lists 5 drug label records with SODIUM SULFACETAMIDE, 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.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | KMM Pharmaceuticals, LLC | 3 |
| — | — | ACELLA PHARMACEUTICALS | 1 |
| — | — | Cintex Services, LLC | 1 |
| — | — | — | — |
| — | — | — | — |
Recall and safety notices
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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0523-2026 | NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16 | Acella Pharmaceuticals, LLC | Class II | Ongoing | 20260513 |
| D-0014-2026 | Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. | Acella Pharmaceuticals, LLC | Class II | Ongoing | 20251015 |
| D-0490-2024 | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06 | Acella Pharmaceuticals, LLC | Class III | Terminated | 20240515 |
| D-0074-2023 | Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60 | Acella Pharmaceuticals, LLC | Class III | Terminated | 20221207 |
| D-0069-2023 | Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 | Acella Pharmaceuticals, LLC | Class III | Terminated | 20221130 |
Frequently asked questions
What is SODIUM SULFACETAMIDE - SULFUR WASH used for?
INDICATIONS: Sodium Sulfacetamide 9% - Sulfur 4% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Who makes SODIUM SULFACETAMIDE - SULFUR WASH?
ACELLA PHARMACEUTICALS is the labeler of record for SODIUM SULFACETAMIDE - SULFUR WASH. 5 FDA label records share the active ingredient SODIUM SULFACETAMIDE, 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 - SULFUR WASH 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 - SULFUR WASH 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 SODIUM SULFACETAMIDE, SULFUR?
Yes. 5 FDA drug label records list SODIUM SULFACETAMIDE, 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 - SULFUR WASH 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.