Indications and uses
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sodium Sulfacetamide 9 Sulfur 4.5 Wash
- Manufacturer
- Trinity Pharmaceuticals, LLC
- Effective date
- 2021-04-21
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:46:07
Label at a glance#
ProductSodium Sulfacetamide 9 Sulfur 4.5 Wash
Active ingredientSulfacetamide Sodium, Sulfur
Label structure12 sections
Dosage and administration
Apply Sodium Sulfacetamide 9% & Sulfur 4.5% 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 lather. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 9% & Sulfur 4.5% Wash sooner or using less often.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx only
DESCRIPTION
Sodium Sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, Sodium Sulfacetamide is N-[(4-aminophenyl)sulfony]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each mL of Sodium Sulfacetamide 9% & Sulfur 4.5% Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: aloe vera, fragrance, butylated hydroxytoluene, cetyl alcohol, disodium EDTA, disodium oleamido MEA sulfosuccinate, glyceryl stearate (and) PEG-100 stearate, green tea extract, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl tau rate, sodium thiosulfate, stearyl alcohol and xanthan gum.
CLINICAL PHARMACOLOGY
The most widely accepted mechanism of action of sulfonamides in 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 unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
INDICATIONS AND USAGE
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9% & Sulfur 4.5% Wash 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.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
PRECAUTIONS
General
If irritation develops, use of this product should be discontinued and appropriate therapy instituted. Patients should be very 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.
Information for Patients
Avoid contact with eyes, eyelids, lips and mucuos membranes. If accidental contact occures, rinse with water. If excessive irritation develops, discontinue use and consult your physician.
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 9% & Sulfur 4.5% Wash. It is also not known whether Sodium Sulfacetamide 9% & Sulfur 4.5% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9% & Sulfur 4.5% Wash 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 9% & Sulfur 4.5% Wash. 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 9% & Sulfur 4.5% Wash is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children under the age of 12 has not been established.
ADVERSE REACTIONS
Although rare, sodium sulfacetamide may cause local irritation.
DOSAGE AND ADMINISTRATION
Apply Sodium Sulfacetamide 9% & Sulfur 4.5% 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 lather. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 9% & Sulfur 4.5% Wash sooner or using less often.
HOW SUPPLIED
Sodium Sulfacetamide 9% & Sulfur 4.5% Wash is available in in a 16 oz (454 g) bottle, NDC 54295-301-21.
STORAGE
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F), however such exposure should be minimized. Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
SPL UNCLASSIFIED SECTION
Manufactured by:
Trinity Pharmaceuticals, LLC
2255 Glades Road, Suite 324A, Boca Raton, FL 33431
TrinityPharmallc.com
PRINCIPAL DISPLAY PANEL - 454 g Bottle Label
NDC 54295-301-21
Rx only
For topical use only
Not for ophthalmic use
Sodium
Sulfacetamide 9%
& Sulfur 4.5%
Wash
Trinity
Pharmaceuticals
Net WT. 16 oz. (454 g)
PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton
NDC 54295-301-21
Rx only
For topical use only
Not for ophthalmic use
Sodium
Sulfacetamide 9%
& Sulfur 4.5%
Wash
Trinity
Pharmaceuticals
Net WT. 16 oz. (454 g)
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54295-301-21 | GM - Gram | 54295-301 | c0744090-b6e8-4f68-922d-b6c28d284199 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Sulfacetamide Sodium | ACTIVE INGREDIENT | 4NRT660KJQ | 5 | |
| Sulfur | ACTIVE INGREDIENT | 70FD1KFU70 | 5 | |
| Sulfacetamide | ACTIVE MOIETY | 4965G3J0F5 | 5 | |
| Sulfur | ACTIVE MOIETY | 70FD1KFU70 | 5 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 5 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 5 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 5 | |
| DISODIUM OLEAMIDO MEA-SULFOSUCCINATE | INACTIVE INGREDIENT | 5M1101WGSY | 5 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 5 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 5 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 5 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 5 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 5 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 5 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 5 | |
| SODIUM COCOYL ISETHIONATE | INACTIVE INGREDIENT | 518XTE8493 | 5 | |
| SODIUM METHYL COCOYL TAURATE | INACTIVE INGREDIENT | JVL98CG53G | 5 | |
| SODIUM THIOSULFATE | INACTIVE INGREDIENT | HX1032V43M | 5 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 5 |
Products#
Every source-derived product name is available through these pages.
- Sodium Sulfacetamide 9 Sulfur 4.5 Wash
- Sulfacetamide Sodium and Sulfur
- Sulfacetamide Sodium
- Sulfacetamide
- Sulfur
- ALOE VERA LEAF
- BUTYLATED HYDROXYTOLUENE
- CETYL ALCOHOL
- EDETATE DISODIUM
- DISODIUM OLEAMIDO MEA-SULFOSUCCINATE
- GLYCERIN
- GLYCERYL MONOSTEARATE
- PEG-100 STEARATE
- GREEN TEA LEAF
- MAGNESIUM ALUMINUM SILICATE
- METHYLPARABEN
- PROPYLPARABEN
- WATER
- SODIUM COCOYL ISETHIONATE
- SODIUM METHYL COCOYL TAURATE
- SODIUM THIOSULFATE
- STEARYL ALCOHOL
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54295-301 | 54295-301-21 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | CREAM / TOPICAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SOFT TISSUE | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | CAPSULE / ORAL | 20 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SOLUTION / TOPICAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / TOPICAL | 180 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| PEG-100 STEARATE | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / TOPICAL | 552 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / NASAL | 100 mg/100ml | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET / ORAL | 20 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET / ORAL | 60 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | TABLET, CHEWABLE / ORAL | 12 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | SOLUTION / ORAL | 22 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / ORAL | 30 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| SODIUM METHYL COCOYL TAURATE | SODIUM METHYL COCOYL TAURATE | JVL98CG53G | SHAMPOO / TOPICAL | 65 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION/ DROPS / ORAL | 4.15 mg/2.5ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / RECTAL | 14480 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | SOLUTION/ DROPS / ORAL | 0.5 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAVENOUS | 0.13 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUPPOSITORY / VAGINAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GUM, CHEWING / BUCCAL | 5 mg |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| eac41e38-4adc-97bb-e053-2995a90a356c | a7170c84-fab2-438d-b5b9-a23bfd474ede | 2022-10-10 | Warnings, Adverse reactions | a7170c84-fab2-438d-b5b9-a23bfd474ede |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.