Sodium Sulfacetamide And Sulfur Cleanser
Sulfacetamide Sodium And Sulfur
Bi-coastal Pharma International Llc
Human Prescription Drug
NDC 42582-800Sodium Sulfacetamide And Sulfur Cleanser also known as Sulfacetamide Sodium And Sulfur is a human prescription drug labeled by 'Bi-coastal Pharma International Llc'. National Drug Code (NDC) number for Sodium Sulfacetamide And Sulfur Cleanser is 42582-800. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Sodium Sulfacetamide And Sulfur Cleanser drug includes Sulfacetamide Sodium - 100 mg/g Sulfur - 20 mg/g . The currest status of Sodium Sulfacetamide And Sulfur Cleanser drug is Active.
Drug Information:
| Drug NDC: | 42582-800 |
| 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 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 And Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bi-coastal Pharma International Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 20 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 Jun, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | Bi-Coastal Pharma International LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1000895
|
| 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. |
| 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 |
|---|
| 42582-800-08 | 227 g in 1 BOTTLE (42582-800-08) | 01 Jun, 2011 | 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 and sulfur cleanser sulfacetamide sodium and sulfur sulfacetamide sodium sulfacetamide sulfur sulfur aloe vera leaf butylated hydroxytoluene green tea leaf cetyl alcohol disodium oleamido monoethanolamine sulfosuccinate edetate disodium glycerin glyceryl monostearate magnesium aluminum silicate methylparaben peg-100 stearate propylparaben water sodium cocoyl isethionate sodium methyl cocoyl taurate sodium thiosulfate stearyl alcohol xanthan gum
Indications and Usage:
Indications sodium sulfacetamide 10% and sulfur 2% 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 .
General Precautions:
General 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.
Dosage and Administration:
Dosage and administration wash affected areas with sodium sulfacetamide 10% and sulfur 2% cleanser one to two times 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 to 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 cleanser less often.
Contraindications:
Contraindications sodium sulfacetamide 10% and sulfur 2% cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sodium sulfacetamide 10% and sulfur 2% cleanser is not to be used by patients with kidney disease.
Adverse Reactions:
Adverse reactions although rare, sodium sulfacetamide may cause local irritation. call your doctor for medical advice about side effects. to report suspected adverse reactions, contact the fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Use in Pregnancy:
Pregnancy category c animal reproduction studies have not been conducted with sodium sulfacetamide 10% and sulfur 2% cleanser. it is also not known whether sodium sulfacetamide 10% and sulfur 2% cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfacetamide 10% and sulfur 2% cleanser should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in children under the age of 12 has not been established.
Description:
Description each gram of sodium sulfacetamide and sulfur (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in a vehicle consisting of: aloe barbadensis (aloe vera) leaf extract, butylated hydroxytoluene, camellia oleifera (green tea) leaf extract, cetyl alcohol, disodium oleamido mea sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl monostearate, magnesium aluminum silicate, methylparaben, peg-100 stearate, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xantham 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 3 sâh 2 o with molecular weight of 254.24. chemically, it is n-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. the structural formula is: chemical structure
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis and impairment of fertility long-term studies in animals have not been performed to evaluate carcinogenic potential.
How Supplied:
How supplied sodium sulfacetamide 10% and sulfur 2% cleanser is supplied in an 8 oz. (227 g) bottle, ndc 42582-800-08. store at 25°c (77°f); excursions permitted to between 15°c to 30°c (59°f to 86°f). see usp controlled room temperature. note: 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 tube or packet tightly closed. occasionally, a slight yellowish discoloration 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.
Package Label Principal Display Panel:
Principal display panel - 227 g bottle label ndc 42582-800-08 rx only sodium sulfacetamide 10% and sulfur 2% cleanser (sodium sulfacetamide 10%, sulfur 2%) net wt. 8 oz. (227 g) bi-coastal pharma international llc principal display panel - 227 g bottle label