Apply Sumadan ® (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 full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sumadan ® (sodium sulfacetamide 9% & sulfur 4.5%) Wash sooner or using le...
www.fda.gov/medwatch
www.medimetriks.comRx Only
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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a formulation consisting of: butylated hydroxytoluene, C12-15 alkyl benzoate, caprylyl glycol, cetyl alcohol, cholesterol, chrysanthemum dendranthema, dimethicone, disodium oleamido MIPA sulfosuccinate, edetate disodium, ethylene brassilate, glyceryl stearate, hexylene glycol, lemon oil, magnesium aluminum silicate, magnesium chloride, magnesium nitrate, methylchloroisothiazolinone, methylisothiazolinone, niacinamide, nonoxynol-20, octoxynol-5, purified water, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium cocoyl isotheionite, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, 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 unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash 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.
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 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.
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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash. It is also not known whether Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash 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 Sumadan® (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 Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash 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.
Apply Sumadan® (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 full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash sooner or using less often.
Sumadan® (sodium sulfacetamide 9% & sulfur 4.5%) Wash is available in a Net wt. 16 oz. (454 g) bottle, NDC 43538-190-16.
Sumadan® KIT contents one unit of Sumadan® Wash, Net wt. 16 oz. (454 g) and one unit of Rehyla® Wash, 16 oz. bottle, NDC 43538-191-16.
Sumadan® XLT contents one unit of Sumadan® Wash, Net wt. 16 oz. (454 g) bottle and one unit of Niseko® Sunscreen, 3 oz. tube, NDC 43538-192-16.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.
383 Route 46 West
Fairfield, NJ 07004-2402 USA
IP022-R3
Rev. 10/17
NDC 43538-192-16
Rx Only
Sumadan®
(Sodium Sulfacetamide 9% & Sulfur 4.5%)
XLT
KIT CONTENTS:
1 - Sumadan® (Sodium Sulfacetamide 9% & Sulfur 4.5%) Wash (Net Wt. 16 oz.)
1 - Niseko® Sunscreen Broad Spectrum SPF 25 (Net Wt. 3 oz.)
MEDIMETRIKS
PHARMACEUTICALS, INC.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43538-192-16 | 2023-12-14 | C162847 | 48780-1 | ba0f9c33-101b-a910-e053-dadaa90a0b85 | Sumadan ® (Sodium Sulfacetamide 9% & Sulfur 4.5%) WASH In a Moisturizing Novasome ® Vehicle |
| 43538-192-16 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-101b-a910-e053-dadaa90a0b85 | Sumadan ® (Sodium Sulfacetamide 9% & Sulfur 4.5%) WASH In a Moisturizing Novasome ® Vehicle |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43538-192-16 | GM - Gram | 43538-192 | 2b0161b2-b10a-4f5c-9a8d-d913aa9da184 | 1 | 2014-01-04 |
| 43538-190-16 | GM - Gram | 43538-190 | ca9e6f0f-1768-40c7-83fa-99354857fa1a | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| sulfacetamide sodium | ACTIVE INGREDIENT | 4NRT660KJQ | 1 | |
| sulfur | ACTIVE INGREDIENT | 70FD1KFU70 | 1 | |
| avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| sulfacetamide | ACTIVE MOIETY | 4965G3J0F5 | 1 | |
| sulfur | ACTIVE MOIETY | 70FD1KFU70 | 1 | |
| .alpha.-tocopherol acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| Alkyl (C12-15) Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| butylated hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| butyloctyl salicylate | INACTIVE INGREDIENT | 2EH13UN8D3 | 1 | |
| C13-14 isoparaffin | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| caprylyl glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| ceteth-10 phosphate | INACTIVE INGREDIENT | 4E05O5N49G | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| cholesterol | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| dihexadecyl phosphate | INACTIVE INGREDIENT | 2V6E5WN99N | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| disodium oleamido MIPA-sulfosuccinate | INACTIVE INGREDIENT | 0MBZ20845F | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| glyceryl stearate SE | INACTIVE INGREDIENT | FCZ5MH785I | 1 | |
| green tea leaf | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| hexylene glycol | INACTIVE INGREDIENT | KEH0A3F75J | 1 | |
| isododecane | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| laureth-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| lemon oil | INACTIVE INGREDIENT | I9GRO824LL | 1 | |
| magnesium aluminum silicate | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| magnesium chloride | INACTIVE INGREDIENT | 02F3473H9O | 1 | |
| magnesium nitrate | INACTIVE INGREDIENT | 77CBG3UN78 | 1 | |
| methylchloroisothiazolinone | INACTIVE INGREDIENT | DEL7T5QRPN | 1 | |
| methylisothiazolinone | INACTIVE INGREDIENT | 229D0E1QFA | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| niacinamide | INACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| nonoxynol-20 | INACTIVE INGREDIENT | 60ZT1XYO5N | 1 | |
| octoxynol-5 | INACTIVE INGREDIENT | TJ327E1R1V | 1 | |
| PEG-100 stearate | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 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 |
|---|---|
| 43538-192 | 43538-192-16 |
| 43538-190 | 43538-190-16 |
| 43538-290 | 43538-290-03 |
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 |
|---|---|---|---|---|---|---|
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | EMULSION / ORAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 0.02 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| hexylene glycol | HEXYLENE GLYCOL | KEH0A3F75J | OINTMENT / TOPICAL | 12 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | LOTION / TOPICAL | 3627 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION / INTRAVENOUS | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| niacinamide | NIACINAMIDE | 25X51I8RD4 | INJECTION / INTRAMUSCULAR | 2.5 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| sodium thiosulfate | SODIUM THIOSULFATE | HX1032V43M | CAPSULE / ORAL | 20 mg | ||
| phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| niacinamide | NIACINAMIDE | 25X51I8RD4 | CREAM / TOPICAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | AEROSOL, FOAM / TOPICAL | 4 mg | ||
| magnesium aluminum silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CONCENTRATE / ORAL | 410 mg/5ml | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, LIQUID FILLED / ORAL | 0.1 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| sodium thiosulfate | SODIUM THIOSULFATE | HX1032V43M | SUSPENSION / OPHTHALMIC | 0.32 %w/w | ||
| magnesium aluminum silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SYRUP / ORAL | 100 mg/1ml | ||
| hexylene glycol | HEXYLENE GLYCOL | KEH0A3F75J | SOLUTION / TOPICAL | 0.3 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET / ORAL | 20 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg |
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 |
|---|---|---|---|---|---|---|
| 71f350c4-1d00-4b6c-b837-0cad1c57f9f8 | f4b493b8-1193-4a3f-b7a2-77d08d5b3d66 | 2023-10-30 | Warnings, Adverse reactions | f4b493b8-1193-4a3f-b7a2-77d08d5b3d66 |
Adverse event summaries are temporarily unavailable. Other product information remains available.