Apply Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension 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 8% and Sulfur 4% Topical Suspension sooner or usin...
In a vehicle containing Green Tea and Aloe
Rx Only
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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:
Each mL of Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension contains 80 mg of Sodium Sulfacetamide and 40 mg of Sulfur in a formulation containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, Green Tea Extract, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum.
The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
This product is contraindicated for use by persons with known or suspected hypersensitivity to sulfonamides, sulfur or any other component of this preparation. This product is not to be used by patients with kidney disease.
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.
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 longterm 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 possibilty.
Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Animal reproduction studies have not been conducted with Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension. It is not known whether Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension should be given to a pregnant woman only if clearly needed.
It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is administered to a nursing woman.
Safety and effectiveness in children under the age of 12 have not been established.
Although rare, sodium sulfacetamide may cause local irritation.
Call your doctor for medical advice about side effects. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294.
The oral LD50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately.
Overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center (1-800-222-1222), or your doctor.
Apply Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension 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 8% and Sulfur 4% Topical Suspension sooner or using less often.
Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is available in 16 fl oz (473 mL) bottles, NDC 69367-245-16.
Store at controlled room temperature, 15° - 30°C (59° - 86°F). Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person's professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.
Manufactured for:
Westminster Pharmaceuticals LLC
Nashville TN, 37217
Rev. 05/23
NDC: 69367-245-16
Rx Only
Peel Here
Sodium
Sulfacetamide 8%
and Sulfur 4%
Topical Suspension
In a vehicle containing
Green Tea and Aloe
SHAKE WELL
16 fl. oz. (473 mL)
Westminster
Pharmaceuticals
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1010234 | sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid Soap | PSN | 8 |
| 1010234 | sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid Soap | SCD | 8 |
| 1010234 | sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid Soap | SY | 8 |
| 1010234 | sulfacetamide sodium 8 % / sulfur 4 % Topical Suspension | SY | 8 |
| Class | Version | Type | Effective |
|---|---|---|---|
| SULFACETAMIDE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4073022c-5d5d-48f5-82ed-091ad146a4b2 | Product name | 1 | 20171211 |
| 9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5 | Product name | 1 | 20150828 |
| 0304b7d2-7a07-d53b-750f-36012ae6612e | Product name | 1 | 20140508 |
| 64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6 | Product name | 1 | 20140508 |
| 9ae74339-0a3d-82e9-5dd1-88bd2607bd6b | Product name | 1 | 20140508 |
| e44e38a9-2d9e-b0e2-cce9-490554639f3d | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69367-245-16 | Sodium Sulfacetamide and Sulfur | 473 mL in 1 BOTTLE | SUSPENSION | 473 | 8 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69367-245-16 | ML - Milliliter | 69367-245 | 148e5b1b-6e6f-4141-8147-1d3d4b62effd | 1 | 2021-08-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69367-245 | 69367-245-16 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sodium Sulfacetamide and Sulfur | SODIUM SULFACETAMIDE AND SULFUR | Westminster Pharmaceuticals, LLC | e9b60d3f-3f3f-477d-92d7-fe0ba07e21de | 2025-04-29 | Warnings, Adverse reactions | 69367-245-16 69367-245 69367024516 b4e89e57-397a-4578-bc59-709cb46db033 e9b60d3f-3f3f-477d-92d7-fe0ba07e21de |
Adverse event summaries are temporarily unavailable. Other product information remains available.