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 cle...
www.fda.gov/medwatchRx Only
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Each gram of Sodium Sulfacetamide and Sulfur (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: aloe barbadensis (aloe vera) leaf extract, butylated hydroxytoluene, camellia oleifera (green tea) leaf extract, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl monostearate, magnesium aluminum silicate, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xantham gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C8H9N2NaO3S∙H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
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 unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
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.
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.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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.
Long-term studies in animals have not been performed to evaluate carcinogenic potential.
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.
It is not known whether sodium sulfacetamide is excreted in human milk following topicaI 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.
Safety and effectiveness in children under the age of 12 has not been established.
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.
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.
Sodium Sulfacetamide 10% and Sulfur 2% Cleanser is supplied in an 8 oz. (227 g) bottle, NDC 42582-800-08.
Store at 25°C (77°F); excursions permitted to between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
Note: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep tube or packet tightly closed.
Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.
Manufactured for:
Bi-Coastal Pharma International LLC
Red Bank, New Jersey 07701 USA
12/14
NDC 42582-800-08
Rx Only
SODIUM
SULFACETAMIDE 10%
AND SULFUR 2%
Cleanser
(sodium sulfacetamide 10%, sulfur 2%)
Net Wt. 8 oz. (227 g)
Bi-Coastal Pharma International LLC
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42582-800-08 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-4d11-f424-e053-dadaa90a57ce | Sodium Sulfacetamide 10% and Sulfur 2% Cleanser (Sodium Sulfacetamide 10%, Sulfur 2%) |
| 42582-800-08 | 2020-03-03 | C162847 | 48780-1 | 9d75b9d0-4d11-f424-e053-dadaa90a57ce | Sodium Sulfacetamide 10% and Sulfur 2% Cleanser (Sodium Sulfacetamide 10%, Sulfur 2%) |
| 42582-800-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4d11-f424-e053-dadaa90a57ce | Sodium Sulfacetamide 10% and Sulfur 2% Cleanser (Sodium Sulfacetamide 10%, Sulfur 2%) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42582-800-08 | Sodium Sulfacetamide and Sulfur Cleanser | 227 g in 1 BOTTLE | CREAM | 227 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42582-800-08 | GM - Gram | 42582-800 | 58760bc1-ad1c-4a09-8a3b-a97ed2ec61bc | 1 | 2015-10-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SULFACETAMIDE SODIUM | ACTIVE INGREDIENT | 4NRT660KJQ | 1 | |
| SULFUR | ACTIVE INGREDIENT | 70FD1KFU70 | 1 | |
| SULFACETAMIDE | ACTIVE MOIETY | 4965G3J0F5 | 1 | |
| SULFUR | ACTIVE MOIETY | 70FD1KFU70 | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| DISODIUM OLEAMIDO MEA-SULFOSUCCINATE | INACTIVE INGREDIENT | 5M1101WGSY | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PEG-100 STEARATE | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM COCOYL ISETHIONATE | INACTIVE INGREDIENT | 518XTE8493 | 1 | |
| SODIUM METHYL COCOYL TAURATE | INACTIVE INGREDIENT | JVL98CG53G | 1 | |
| SODIUM THIOSULFATE | INACTIVE INGREDIENT | HX1032V43M | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42582-800 | 42582-800-08 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOTION / TOPICAL | 0.3 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | EMULSION / TOPICAL | 0.06 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / AURICULAR (OTIC) | 0.1 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | TABLET / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET / ORAL | 20 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / RECTAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / NASAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SYRUP / ORAL | 100 mg/1ml | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / VAGINAL | 140 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUPPOSITORY / VAGINAL | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | GRANULE, FOR SUSPENSION / ORAL | 12.5 mg/5ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / VAGINAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| SODIUM THIOSULFATE | SODIUM THIOSULFATE | HX1032V43M | SUSPENSION/ DROPS / OPHTHALMIC | 3.15 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 1105962f-1a95-44ef-9e69-d61f5a501eb7 | 1aa63fb0-05d9-426a-aa45-264373a23d9f | 2022-01-18 | Warnings, Adverse reactions | 1105962f-1a95-44ef-9e69-d61f5a501eb7 1aa63fb0-05d9-426a-aa45-264373a23d9f |
Adverse event summaries are temporarily unavailable. Other product information remains available.