Sodium Sulfacetamide And Sulfur

Sulfacetamide Sodium, Sulfur

Method Pharmaceuticals, Llc
Human Prescription Drug
NDC 58657-472

Sodium Sulfacetamide And Sulfur also known as Sulfacetamide Sodium, Sulfur is a human prescription drug labeled by 'Method Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Sulfacetamide And Sulfur is 58657-472. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Sodium Sulfacetamide And Sulfur drug includes Sulfacetamide Sodium - 100 mg/g Sulfur - 50 mg/g . The currest status of Sodium Sulfacetamide And Sulfur drug is Active.

Drug Information:

Drug NDC:	58657-472
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 And Sulfur
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, Llc
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 - 100 mg/g SULFUR - 50 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:	15 Nov, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 Jan, 2026
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, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	999613
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:	0358657472085 0358657472078
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
58657-472-06	170 g in 1 BOTTLE, PLASTIC (58657-472-06)	15 Nov, 2021	N/A	No
58657-472-07	170.3 g in 1 BOTTLE, PLASTIC (58657-472-07)	15 Nov, 2021	N/A	No
58657-472-08	227 g in 1 BOTTLE, PLASTIC (58657-472-08)	15 Nov, 2021	N/A	No
58657-472-12	340 g in 1 BOTTLE, PLASTIC (58657-472-12)	15 Nov, 2021	N/A	No
58657-472-13	340.2 g in 1 BOTTLE, PLASTIC (58657-472-13)	15 Nov, 2021	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.

Other medicines with the same generic name

Sodium Sulfacetamide And Sulfur

Sulfacetamide Sodium, Sulfur

Liquid
Bryant Ranch Prepack
NDC: 63629-9259

Sodium Sulfacetamide And Sulfur

Sulfacetamide Sodium, Sulfur

Liquid
Bryant Ranch Prepack
NDC: 63629-9261

Sodium Sulfacetamide 9% - Sulfur 4.5% Wash

Sulfacetamide Sodium, Sulfur

Liquid
Akron Pharma Inc.
NDC: 71399-0484

Sodium Sulfacetamide, Sulfur

Sulfacetamide Sodium, Sulfur

Emulsion
BioComp Pharma, Inc.
NDC: 44523-550

Sodium Sulfacetamide 10% And Sulfur 5% Cleanser

Sulfacetamide Sodium, Sulfur

Liquid
Akron Pharma Inc.
NDC: 71399-0488

Plexion

Sulfacetamide Sodium, Sulfur

Cream
Eckson Labs LLC
NDC: 44118-701

Plexion

Sulfacetamide Sodium, Sulfur

Cloth
Eckson Labs LLC
NDC: 44118-702

Sulfacetamide Sodium, Sulfur

Emulsion
BioComp Pharma, Inc.
NDC: 44523-560

Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser

Sulfacetamide Sodium, Sulfur

Liquid
Rosemar Labs, LLC
NDC: 50096-502

Sodium Sulfacetamide 9.8% And Sulfur 4.8% Cleanser

Sulfacetamide Sodium, Sulfur

Liquid
KMM Pharmaceuticals, LLC
NDC: 52187-546

Product Elements:

Sodium sulfacetamide and sulfur sulfacetamide sodium, sulfur butylated hydroxytoluene aloe vera leaf 1-ethyl citrate cetyl alcohol edetate disodium glyceryl stearate se peg-100 stearate cocamidopropyl betaine triacetin water sodium thiosulfate sodium lauryl sulfate stearyl alcohol xanthan gum glycerin phenoxyethanol sulfacetamide sodium sulfacetamide sulfur sulfur

Indications and Usage:

Indications sodium sulfacetamide 10% - sulfur 5% cleanser is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Warnings:

Warnings 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. sulfonamides are known to cause stevens-johnson syndrome in hypersensitive individuals. stevens-johnson syndrome also has been reported following the use of sodium sulfacetamide topically. cases of drug induced systemic lupus erythematosus from topical sulfacetamide also have been reported. in one of these cases, there was a fatal outcome. keep out of reach of children.

Dosage and Administration:

Dosage and administration use: 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. for external use only. not for intravaginal or ophthalmic use. (keep away from eyes). keep out of reach of children.

Contraindications:

Contraindications: sodium sulfacetamide 10% & sulfur 5% cleanser is contraindicated in persons with know or suspected hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sodium sulfacetamide 10% & sulfur 5% cleanser is not to be used by patients with kidney disease.

Description:

Description each gram of sodium sulfacetamide 10% and sulfur 5% cleanser contains 100 mg of sodium sulfacetamide and 50 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 3sÂ·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 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.

Package Label Principal Display Panel:

Package label label label label label label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.