Sodium Sulfacetamide 10% And Sulfur 5% Emollient Foam
Sulfacetamide Sodium And Sulfur
Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-143Sodium Sulfacetamide 10% And Sulfur 5% Emollient Foam also known as Sulfacetamide Sodium And Sulfur is a human prescription drug labeled by 'Acella Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Sulfacetamide 10% And Sulfur 5% Emollient Foam is 42192-143. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Sodium Sulfacetamide 10% And Sulfur 5% Emollient Foam drug includes Sulfacetamide Sodium - 10 mg/g Sulfur - 5 mg/g . The currest status of Sodium Sulfacetamide 10% And Sulfur 5% Emollient Foam drug is Active.
Drug Information:
| Drug NDC: | 42192-143 |
| 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 10% And Sulfur 5% Emollient Foam |
| 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: | Acella Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Foam |
| 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 - 10 mg/g
SULFUR - 5 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: | 18 Jun, 2013 |
| 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: | 1005853
|
| 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: | 0342192143012
|
| 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 |
|---|
| 42192-143-01 | 100 g in 1 CAN (42192-143-01) | 18 Jun, 2013 | 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 10% and sulfur 5% emollient foam sulfacetamide sodium and sulfur sulfacetamide sodium sulfacetamide sulfur sulfur butane butylene glycol carboxymethylcellulose sodium, unspecified form polyoxyl 20 cetostearyl ether cetostearyl alcohol dimethicone glycerin magnesium aluminum silicate polysorbate 20 propane titanium dioxide water
Indications and Usage:
Indications sss 10 - 5 emollient foam is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Warnings:
Warnings although rare, sensitivity to sodium sulfacetamide may occur. stevens-johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. hypersensitivity reactions may occur when a sulfonamide is readministered, irrespective of the route of administration. at the first sign of hypersensitivity or skin rash, discontinue use of this preparation. particular caution should be employed if areas of involved skin to be treated are denuded or abraded.
General Precautions:
For external use only. keep away from eyes. keep out of reach of children. contents under pressure. do not puncture or incinerate container. do not expose to temperatures above 120°f (49°c).
General the object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the skin. these side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. 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. information for patients - avoid contact with eyes, eyelids, lips and mucous membranes. if accidental contact occurs, rinse with water. if excessive irritation develops, discontinue use and consult your physician.
Dosage and Administration:
Dosage and administration wash affected areas before use, 1 to 2 times daily as directed by physician. before each use, shake can vigorously, then gently tap the bottom of the can on a firm surface or in palm of other hand. tap can 1 - 2 times, then shake and tap again. dispense can upright. depress the actuator and dispense a small amount of foam (not more than a dollop the size of a golf ball). pointing the can down will cause propellant loss. wash affected areas and apply foam 1 or 2 times a day as directed by a physician. avoid contact with the eyes. wash-off application: massage the dispensed foam into the affected areas and wait 1 to 2 minutes. rinse thoroughly with water and pat dry. treat the affected area 1 to 2 times daily, as directed by a physician. leave-on application: massage the foam into the affected areas 1 to 2 times daily, as directed by a physician. wipe off any excess foam from actuator after use.
Contraindications:
Contraindications sss 10 - 5 emollient foam is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sss 10 - 5 emollient foam 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 sss 10 - 5 emollient foam. when administered to a pregnant woman, it also is not known whether sss 10 - 5 emollient foam can affect reproduction capacity or cause fetal harm. sss 10 - 5 emollient foam 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 sodium sulfacetamide is a sulfonamide with antibacterial activity. sulfur acts as a keratolytic agent. chemically sodium sulfacetamide is n-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. the structural formula is: each gram of sss 10 - 5 emollient foam contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in an aqueous based emollient foam vehicle containing: butane, butylene glycol, cellulose gum, ceteareth-20, cetearyl alcohol, dimethicone, glycerin, magnesium aluminum silicate, polysorbate 20, propane, titanium dioxide, water. chemical structure
Clinical Pharmacology:
Clinical pharmacology sodium sulfacetamide exhibits antibacterial activity. 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 is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. furthermore, in combination with sulfacetamide, sulfur has been reported to inhibit the growth of propionibacterium acnes, thereby adding to the productâs antibacterial activity and reducing associated inflammation.
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 sss 10 - 5 emollient foam is available in a 100 g aluminum can, ndc 42192-143-01. contents under pressure. do not puncture or incinerate container. do not expose to heat or store at temperatures above 120°f (49°c). storage: store sss 10 - 5 emollient foam between 68° and 77°f (20° and 25°c). protect from freezing. store upright. keep this and all medications out of the reach of children. all prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. please note: this is not an orange book product and has not been subjected to fda therapeutic equivalency or other equivalency. no representation is made as to generic status or bioequivalency. each person recommending a prescription substitution using this product shall make such recommendations based on each such personâs professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredient
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Package Label Principal Display Panel:
Principal display panel - 100 g bottle label ndc 42192-143-01 sss 10 - 5 (sodium sulfacetamide 10% and sulfur 5%) emollient foam rx only for dermatologic use only. not for opthaamic use. 100 g acella pharmaceuticals, llc principal display panel - 227 g bottle label