Sodium Sulfacetamide 9% And Sulfur 4.5% Cleanser
Sulfacetamide Sodium, Sulfur
Method Pharmaceuticals
Human Prescription Drug
NDC 58657-474Sodium Sulfacetamide 9% And Sulfur 4.5% Cleanser also known as Sulfacetamide Sodium, Sulfur is a human prescription drug labeled by 'Method Pharmaceuticals'. National Drug Code (NDC) number for Sodium Sulfacetamide 9% And Sulfur 4.5% Cleanser is 58657-474. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Sodium Sulfacetamide 9% And Sulfur 4.5% Cleanser drug includes Sulfacetamide Sodium - 90 mg/g Sulfur - 45 mg/g . The currest status of Sodium Sulfacetamide 9% And Sulfur 4.5% Cleanser drug is Active.
Drug Information:
| Drug NDC: | 58657-474 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sodium Sulfacetamide 9% And Sulfur 4.5% Cleanser |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sulfacetamide Sodium, Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Method Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SULFACETAMIDE SODIUM - 90 mg/g
SULFUR - 45 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Method Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1115894
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0358657474164
|
| UPC stands for Universal Product Code. |
| UNII: | 4NRT660KJQ
70FD1KFU70
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Sulfonamide Antibacterial [EPC]
Sulfonamides [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 58657-474-16 | 454 g in 1 BOTTLE, PLASTIC (58657-474-16) | 01 Feb, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Sodium sulfacetamide 9% and sulfur 4.5% cleanser sulfacetamide sodium, sulfur phenoxyethanol triacetin aloe vera leaf butylated hydroxytoluene cocamidopropyl betaine cetyl alcohol edetate disodium glyceryl stearate se peg-100 stearate water sodium thiosulfate sodium lauryl sulfate stearyl alcohol xanthan gum sulfacetamide sodium sulfacetamide sulfur sulfur
Indications and Usage:
Indications sodium sulfacetamide 9% - sulfur 4.5% cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Warnings:
Warnings although it is 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. not for intravaginal or ophthalmic use. (keep away from eyes). keep out of reach of children. in case of accidental ingestion contact a poison control center immediately. keepcontainer tightly closed.
Dosage and Administration:
Dosage and administration wash affected area once or twice 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 10-20 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 less often. see label booklet for full prescribing information.
Contraindications:
Contraindications: sodium sulfacetamide 9% - sulfur 4.5% cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sodium sulfacetamide 9% - sulfur 4.5% cleanser is not to be used by patients with kidney disease.
Adverse Reactions:
Adverse reaction although rare, sodium sulfacetamide may cause local irritation. call your doctor for medical advice about side effects. to report a serious adverse event or obtain product information, call 1-877-250-3427.
Description:
Description each gram of sodium sulfacetamide 9% and sulfur 4.5% cleanser contains 90 mg of sodium sulfacetamide and 45 mg of sulfur in a cleanser containing aloe vera leaf extract, butylated hydroxytoluene, cetyl alcohol, citric acid, cocamidopropyl betaine, disodium edta, glycerin, glyceryl stearate se, peg-100 stearate, phenoxyethanol, purified water, sodium laureth sulfate, sodium thiosulfate, stearyl alcohol, triacetin, xanthan gum. sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. sodium sulfacetamide is c 8 h 9 n 2 nao 3s·h2o with molecular weight of 254.24. chemically, it is n-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. the structural formula is: struct
Clinical Pharmacology:
Clinical pharmacology sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive gram-positive and gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. it acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. there is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. however, significant absorption of sodium sulfacetamide through the skin has been reported. the following in vitro data is available but the clinical significance is unknown. organisms that show susceptibility to sodium sulfacetamide are: streptococci, staphylococci, e. coli, klebsiella pneumoniae, pseudomonas pyocyanea, salmonella species, proteus vulgaris, nocardia and actinomyces. 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 propi
Read more...onibacterium acnes and the formation of free fatty acids.
How Supplied:
How supplied store at 20°c to 25°c (68°f to 77°f), excursions permitted between 15°c and 30°c (between 59°f and 86°f). brief exposure to temperatures up to 40°c (104°f) may be tolerated provided the mean kinetic temperature does not exceed 25°c (77°f); however, such exposure should be minimized. notice: 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 bottle tightly closed. occasionally, a slight discoloration of fabric 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. this bottle is not filled to the top but does contain 16 fl oz of product as identified on the front panel of the bottle.
Package Label Principal Display Panel:
Label