Sodium Sulfacetamide And Sulfur Wash
Sodium Sulfacetamide And Sulfur
Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-104Sodium Sulfacetamide And Sulfur Wash also known as Sodium Sulfacetamide And Sulfur is a human prescription drug labeled by 'Acella Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Sulfacetamide And Sulfur Wash is 42192-104. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Sodium Sulfacetamide And Sulfur Wash drug includes Sulfacetamide Sodium - 100 mg/g Sulfur - 10 mg/g . The currest status of Sodium Sulfacetamide And Sulfur Wash drug is Active.
Drug Information:
| Drug NDC: | 42192-104 |
| 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 Wash |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Sodium Sulfacetamide And Sulfur |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Wash |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Sodium Sulfacetamide And Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Acella 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 - 10 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: | 04 Jun, 2008 |
| 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: | Acella Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 999604
|
| 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 |
|---|
| 42192-104-06 | 1 TUBE in 1 CARTON (42192-104-06) / 170.1 g in 1 TUBE | 04 Jun, 2008 | 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 wash sodium sulfacetamide and sulfur butylated hydroxytoluene cetyl alcohol edetate disodium glyceryl monostearate peg-100 stearate lactic acid magnesium aluminum silicate methylparaben propylparaben water sodium c14-16 olefin sulfonate sodium hydroxide sodium thiosulfate stearyl alcohol petrolatum xanthan gum sulfacetamide sodium sulfacetamide sulfur sulfur
Indications and Usage:
Indications and usage: bp 10-1 wash is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Warnings and Cautions:
Warnings: sensitivity to sodium sulfacetamide may occur, although it is rare. 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 tube tightly closed.
Dosage and Administration:
Dosage and administration: wash affected areas 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 treated, 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 wash off sooner or using less often.
Contraindications:
Contraindications: bp 10-1 wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. bp 10-1 wash is not to be used by patients with kidney disease.
Adverse Reactions:
Adverse reactions: although rare, sodium sulfacetamide may cause local irritation.
Use in Pregnancy:
Pregnancy - category c. animal reproduction studies have not been conducted with bp 10-1 wash. it is also not known whether bp 10-1 wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bp 10-1 wash 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 have not been established.
Description:
Description: each gram of bp 10-1 wash contains 100 mg of sodium sulfacetamide and 10 mg of sulfur in a wash containing butylated hydroxytoluene, cetyl alcohol, edetate disodium, glyceryl stearate and peg-100 stearate, lactic acid, magnesium aluminum silicate, methylparaben, propylparaben, purified water, sodium c14-16 olefin sulfonate, sodium hydroxide, sodium thiosulfate, stearyl alcohol, white petrolatum, and xanthan gum. 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: 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: bp 10-1 wash is available in 170.1 g (6.0 oz) tubes, ndc 42192-104-06. store at controlled room temperature, 15°-30°c (59°-86°f).
Package Label Principal Display Panel:
Package label.principal display - 170 g carton ndc 42192-104-06 bp 10-1 (sodium sulfocetamide 10% and sulfur 1%) r x only wash net wt. 6 oz (170.1 g) brookstone pharmaceuticals is now known as acella pharmaceuticals, llc label