Apply Sumaxin ® (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 Sumaxin ® (sodium sulfacetamide 9% & sulfur 4%) Wash sooner or using less o...
www.fda.gov/medwatch
www.medimetriks.comRx Only
In a vehicle containing Green Tea & Aloe
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 mg of Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash contains 90 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation consisting of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glyceryl stearate/PEG-100 stearate, green tea, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, 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.
Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) 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 Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash. It is also not known whether Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) 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 Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) 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 Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash are 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 Sumaxin® (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 Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash sooner or using less often.
Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is available in a 16 oz (454 g) bottle, NDC 43538-130-16.
Store at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.
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.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.
383 Route 46 West
Fairfield, NJ 07004-2402 USA
IP009-R3
Rev. 10/17
NDC 43538-130-16
Rx Only
sumaxin
®
(sodium sulfacetamide 9% & sulfur 4%)
WASH
In a vehicle containing
Green Tea & Aloe
Net Wt. 16 oz. (454 g)
MEDIMETRIKS
PHARMACEUTICALS, INC.
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43538-130-16 | GM - Gram | 43538-130 | ef35d725-fcbf-4333-ab45-de4f95d5a4de | 2 | 2020-01-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Sulfacetamide Sodium | ACTIVE INGREDIENT | 4NRT660KJQ | 4 | |
| Sulfur | ACTIVE INGREDIENT | 70FD1KFU70 | 4 | |
| Sulfacetamide | ACTIVE MOIETY | 4965G3J0F5 | 4 | |
| Sulfur | ACTIVE MOIETY | 70FD1KFU70 | 4 | |
| Aloe | INACTIVE INGREDIENT | V5VD430YW9 | 4 | |
| Butylated hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | 4 | |
| Cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | 4 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 4 | |
| magnesium aluminum silicate | INACTIVE INGREDIENT | 6M3P64V0NC | 4 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 4 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 4 | |
| sodium thiosulfate | INACTIVE INGREDIENT | HX1032V43M | 4 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | 4 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 43538-130 | 43538-130-16 |
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 |
|---|---|---|---|---|---|---|
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| magnesium aluminum silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CREAM / TOPICAL | 3 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| Cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 59 mg | ||
| magnesium aluminum silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | OINTMENT / VAGINAL | 231 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| Cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| Cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| Cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET, EXTENDED RELEASE / ORAL | 132 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAMUSCULAR | 5 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | GEL / VAGINAL | 2 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| Butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SHAMPOO / TOPICAL | 0.1 %w/w | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, EXTENDED RELEASE / ORAL | 244 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRA-ARTICULAR | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| Cetyl alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / TOPICAL | 0.05 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| stearyl alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / VAGINAL | 425 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / NASAL | 2 mg/1ml | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| magnesium aluminum silicate | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | LIQUID / ORAL | 82 mg/5ml | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| Butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / SUBCUTANEOUS | 2 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 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 |
|---|---|---|---|---|---|---|
| 348b8c6b-6614-4b28-8eb7-caf0630b69d1 | e38c5975-2dde-4fe9-8b16-68d807e11ea8 | 2020-12-10 | Warnings, Adverse reactions | e38c5975-2dde-4fe9-8b16-68d807e11ea8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.