Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.
www.fda.gov/medwatch
www.medimetriks.comIn a vehicle containing Green Tea & Aloe
Rx 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 pad of Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl stearate/PEG-100 stearate, green tea, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate, stearyl alcohol.
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 10% & sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are 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 10% & sulfur 4%) Cleansing Pads. It is also not known whether Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads 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 10% & sulfur 4%) Cleansing Pads. 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 10% & sulfur 4%) Cleansing Pads 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.
Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.
Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are available in boxes of 60 cloths (3.7 g), NDC 43538-100-60.
Store at 15°-30° C (59°-86° F).
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
IP001-R5
Rev. 10/17
NDC 43538-100-60
Rx Only
sumaxin®
(sodium sulfacetamide 10% & sulfur 4%)
Cleansing Pads
In a vehicle containing Green Tea & Aloe
60 Cleansing Pads
Net wt. 3.7 g Each
MEDIMETRIKS
PHARMACEUTICALS, INC.
NDC 43538-101-60
Rx Only
sumaxin®
(Sodium Sulfacetamide 10%
& Sulfur 4%) Cleansing Pads
CP
KIT
CONTENTS:
MEDIMETRIKS
PHARMACEUTICALS, INC.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1000946 | sulfacetamide sodium 10 % / sulfur 4 % Medicated Pad | PSN | 3 |
| 1000976 | Sumaxin CP 10 % / 4 % Medicated Pad | PSN | 3 |
| 1000976 | sulfacetamide sodium 100 MG/ML / sulfur 40 MG/ML Medicated Pad [Sumaxin] | SBD | 3 |
| 1000946 | sulfacetamide sodium 100 MG/ML / sulfur 40 MG/ML Medicated Pad | SCD | 3 |
| 1000946 | sulfacetamide sodium 10 % / sulfur 4 % Medicated Pad | SY | 3 |
| 1000946 | sulfacetamide sodium 10 % / sulfur 4 % Topical Swab | SY | 3 |
| 1000976 | Sumaxin CP (sulfacetamide sodium 10 % / sulfur 4 % ) Medicated Pad | SY | 3 |
| 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 |
|---|---|---|---|---|---|
| 43538-100-60 | 2023-12-15 | C162847 | 48780-1 | 0191ceaa-704c-198a-e063-dbdaa90aec3e | sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads |
| 43538-101-60 | 2023-12-15 | C162847 | 48780-1 | 0191ceaa-704c-198a-e063-dbdaa90aec3e | sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads |
| 43538-100-60 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-704c-198a-e063-dbdaa90aec3e | sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads |
| 43538-101-60 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-704c-198a-e063-dbdaa90aec3e | sumaxin ® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43538-100-60 | Sumaxin Cleansing Pads | 60 in 1 CARTON | CLOTH | 60 | 3 | |
| 43538-100-60 | Sumaxin Cleansing Pads | 3.7 g in 1 PACKET | CLOTH | 3.7 | 3 | |
| 43538-101-60 | Sumaxin CP | 1 in 1 CARTON | KIT | 1 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43538-100 | SUMAXIN CLEANSING PADS (SULFACETAMIDE SODIUM AND SULFUR) CLOTH SUMAXIN CP (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231216_5d9ddc1a-fbae-4595-86ce-3bbca7d03482.zip |
| 43538-101 | SUMAXIN CLEANSING PADS (SULFACETAMIDE SODIUM AND SULFUR) CLOTH SUMAXIN CP (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231216_5d9ddc1a-fbae-4595-86ce-3bbca7d03482.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43538-101-60 | EA - Each | 43538-101 | 7e8d57e9-073d-43f2-90b9-1fd82d2ac996 | 1 | 2013-02-13 |
| 43538-100-60 | EA - Each | 43538-100 | 7a5ff65d-0345-42fe-85b1-bac3b57c4a8b | 1 | 2013-02-13 |
| 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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 43538-101 | 43538-101-60 |
| 43538-100 | 43538-100-60 |
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 |
|---|---|---|---|---|---|---|
| Sumaxin Cleansing Pads | SULFACETAMIDE SODIUM AND SULFUR | Medimetriks Pharmaceuticals, Inc. | 5d9ddc1a-fbae-4595-86ce-3bbca7d03482 | 2023-12-15 | Warnings, Adverse reactions | 43538-101-60 43538-100-60 43538-100 43538-101 43538010160 43538010060 10983826-2970-4ff2-87f6-6633c093843f 5d9ddc1a-fbae-4595-86ce-3bbca7d03482 |
Adverse event summaries are temporarily unavailable. Other product information remains available.