Sumaxin Cleansing Pads
Name: Sumaxin Cleansing Pads
Sumaxin Cleansing Pads - Clinical Pharmacology
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.
Contraindications
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.
Adverse Reactions
Although rare, sodium sulfacetamide may cause local irritation.
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 43538-101-60
Rx Only
sumaxin®
(Sodium Sulfacetamide 10%
& Sulfur 4%) Cleansing Pads
CP
KIT
CONTENTS:
1 - Sumaxin® (Sodium Sulfacemide 10% & Sulfur 4%)
Cleansing Pads Carton - 60 Pads (Net wt. 3.7 g each) 1 - Rehyla™ Wash Moisturizing Daily Wash (16 fl. oz.)
MEDIMETRIKS
PHARMACEUTICALS, INC.
SUMAXIN CLEANSING PADS
sulfacetamide sodium and sulfur cloth |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:43538-100 | | Route of Administration | TOPICAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | sulfacetamide sodium (sulfacetamide) | sulfacetamide sodium | 100 mg in 1 g | | Sulfur (sulfur) | Sulfur | 40 mg in 1 g | |
| Inactive Ingredients | | Ingredient Name | Strength | | aloe | | | butylated hydroxytoluene | | | cetyl alcohol | | | disodium oleamido MEA-sulfosuccinate | | | edetate disodium | | | glycerin | | | green tea leaf | | | methylparaben | | | propylparaben | | | water | | | sodium cocoyl isethionate | | | sodium lauryl sulfoacetate | | | sodium thiosulfate | | | stearyl alcohol | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | NDC:43538-100-60 | 60 PACKET (PACKET) in 1 CARTON | | 1 | | 3.7 g in 1 PACKET | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | UNAPPROVED DRUG OTHER | | 01/01/2009 | | |
SUMAXIN CP
sulfacetamide sodium and sulfur kit |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:43538-101 | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:43538-101-60 | 1 KIT (KIT) in 1 CARTON | |
| Quantity of Parts | | Part # | Package Quantity | Total Product Quantity | | Part 1 | 60 PACKET | 222 g | | Part 2 | 1 BOTTLE, PUMP | 454 g | |
| Part 1 of 2 | SUMAXIN CLEANSING PADS
sulfacetamide sodium and sulfur cloth | |
| Product Information | | | Route of Administration | TOPICAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | sulfacetamide sodium (sulfacetamide) | sulfacetamide sodium | 100 mg in 1 g | | sulfur (sulfur) | sulfur | 40 mg in 1 g | |
| Inactive Ingredients | | Ingredient Name | Strength | | aloe | | | butylated hydroxytoluene | | | cetyl alcohol | | | disodium oleamido MEA-sulfosuccinate | | | edetate disodium | | | glycerin | | | green tea leaf | | | methylparaben | | | propylparaben | | | water | | | sodium cocoyl isethionate | | | sodium lauryl sulfoacetate | | | sodium thiosulfate | | | stearyl alcohol | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | | 60 PACKET (PACKET ) in 1 CARTON | | 1 | | 3.7 g in 1 PACKET | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved drug other | | 01/01/2009 | | |
| Part 2 of 2 | REHYLA WASH
inert cream | |
| Product Information | | | Route of Administration | TOPICAL | DEA Schedule | | |
| Inactive Ingredients | | Ingredient Name | Strength | | water | | | glyceryl monostearate | | | glycerin | | | cetyl alcohol | | | disodium oleamido mipa-sulfosuccinate | | | cholesterol | | | disodium laureth sulfosuccinate | | | helianthus annuus seed wax | | | caprylyl glycol | | | propylene glycol | | | phenoxyethanol | | | sodium cocoyl isethionate | | | cocamidopropyl betaine | | | sodium methyl cocoyl taurate | | | C13-14 isoparaffin | | | sodium chloride | | | niacinamide | | | edetate disodium | | | hexylene glycol | | | laureth-7 | | | chamaemelum nobile flower | | | hyaluronate sodium | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | | 1 BOTTLE, PUMP (BOTTLE) in 1 CARTON | | 1 | | 454 g in 1 BOTTLE, PUMP | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Cosmetic | | 08/01/2011 | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved drug other | | 08/01/2011 | | |
| Labeler - Medimetriks Pharmaceuticals, Inc. (019903816) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| IGI Laboratories | | 011036910 | MANUFACTURE |
Revised: 12/2011 Medimetriks Pharmaceuticals, Inc.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Very bad skin irritation.
- Very bad and rarely deadly effects have happened with sulfa (sulfonamide) drugs like this one. These effects have included liver problems, blood problems, and very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis). Call your doctor right away if you have a rash; red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, or eyes; fever, chills, or sore throat; cough that is new or worse; feeling very tired or weak; any bruising or bleeding; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Dry skin.
- Itching.
- Skin irritation.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Some side effects of Sumaxin Cleansing Pads may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
