Sodium Sulfacetamide 10% And Sulfur 5% Cleanser
Sulfacetamide Sodium, Sulfur
Akron Pharma Inc.
Human Prescription Drug
NDC 71399-0488Sodium Sulfacetamide 10% And Sulfur 5% Cleanser also known as Sulfacetamide Sodium, Sulfur is a human prescription drug labeled by 'Akron Pharma Inc.'. National Drug Code (NDC) number for Sodium Sulfacetamide 10% And Sulfur 5% Cleanser is 71399-0488. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Sodium Sulfacetamide 10% And Sulfur 5% Cleanser drug includes Sulfacetamide Sodium - 100 mg/g Sulfur - 50 mg/g . The currest status of Sodium Sulfacetamide 10% And Sulfur 5% Cleanser drug is Active.
Drug Information:
| Drug NDC: | 71399-0488 |
| 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% 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: | Akron Pharma Inc. |
| 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: | 09 Nov, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | Akron Pharma Inc.
|
| 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. |
| 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 |
|---|
| 71399-0488-6 | 170.3 g in 1 BOTTLE, PLASTIC (71399-0488-6) | 09 Nov, 2020 | 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% cleanser sulfacetamide sodium, sulfur sulfacetamide sodium sulfacetamide sulfur sulfur aloe vera leaf cocamidopropyl betaine coco diethanolamide cetyl alcohol edetate disodium glyceryl monostearate methylparaben peg-40 stearate peg-60 almond glycerides propylene glycol water sodium chloride sodium lauryl sulfate sodium metabisulfite sodium thiosulfate xanthan gum
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 wash affected areas with sodium sulfacetamide 10% - sulfur 5% cleanser 1 to 2 times daily or as directed by a 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% - sulfur 5% cleanser is contraindicated for use by patients having known 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.
Adverse Reactions:
Adverse reactions although rare, sodium sulfacetamide may cause local irritation. call your doctor for medical advice about side effects.
Description:
Description each ml of sodium sulfacetamide 10% - sulfur 5% cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a formulation containing aloe vera gel, cocamidopropyl betaine, cocamide dea, cetyl alcohol, disodium edetate, glyceryl monostearate, methylparaben, peg-40 stearate, polyethylene glycol-60, propylene glycol, purified water, sodium chloride, sodium lauryl sulfate, sodium metabisulfite, sodium thiosulfate 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: 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.
How Supplied:
How supplied sodium sulfacetamide 10% - sulfur 5% cleanser is supplied in a 6 oz. (170.3 g) bottle, ndc 71399-0488-6.
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