Sulfacleanse 8/4
Sodium Sulfacetamide And Sulfur
Prugen, Inc.
Human Prescription Drug
NDC 42546-175Sulfacleanse 8/4 also known as Sodium Sulfacetamide And Sulfur is a human prescription drug labeled by 'Prugen, Inc.'. National Drug Code (NDC) number for Sulfacleanse 8/4 is 42546-175. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Sulfacleanse 8/4 drug includes Sulfacetamide Sodium - 80 mg/mL Sulfur - 40 mg/mL . The currest status of Sulfacleanse 8/4 drug is Active.
Drug Information:
| Drug NDC: | 42546-175 |
| 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: | Sulfacleanse 8/4 |
| 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: | Sodium Sulfacetamide And Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Prugen, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - 80 mg/mL
SULFUR - 40 mg/mL
|
| 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 May, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 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: | PruGen, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1010234
|
| 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 |
|---|
| 42546-175-16 | 1 BOTTLE, PUMP in 1 BOX (42546-175-16) / 473 mL in 1 BOTTLE, PUMP | 01 May, 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:
Sulfacleanse 8/4 sodium sulfacetamide and sulfur sulfacetamide sodium sulfacetamide sulfur sulfur aloe butylated hydroxytoluene cetyl alcohol disodium oleamido monoethanolamine sulfosuccinate edetate disodium glyceryl monostearate green tea leaf magnesium aluminum silicate methylparaben peg-100 stearate propylparaben water sodium cocoyl isethionate taurine sodium thiosulfate stearyl alcohol xanthan gum
Indications and Usage:
Indications sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is indicated for 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. for external use only . keep away from eyes. keep out of reach of children. keep container tightly closed.
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 apply sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) once or twice daily to affected areas, or as directed by your physician. 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 off sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) sooner or using less often.
Contraindications:
Contraindications sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) 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 sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) . it is also not known whether sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) 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 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: each ml of sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation consisting of: aloe barbadensis gel, butylated hydroxytoluene, cetyl alcohol, disodium oleamido mea sulfosuccinate, edetate disodium, glyceryl stearate, green tea extract, magnesium aluminum silicate, methylparaben, peg-100 stearate, petrolatum, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum. 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 paraaminobenzoic 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 sulfacleanse ® 8/4 (sodium sulfacetamide 8% & sulfur 4%) is available in a 16 fl. oz. (473 ml) bottle, ndc 42546-175-16. store at 20°c to 25°c (68°f to 77°f), excursions permitted between 15°c and 30°c (between 59°f and 86°f). brief exposure to temperatures up to 40°c (104°f) may be tolerated provided the mean kinetic temperature does not exceed 25°c (77°f); however, such exposure should be minimized. protect from freezing. keep this and all medications out of the reach of children.
Information for Patients:
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.
Package Label Principal Display Panel:
Principal display panel - 473 ml bottle box ndc 42546-175-16 sulfacleanse ® 8 / 4 (sodium sulfacetamide 8% & sulfur 4%) topical suspension in a vehicle containing green tea and aloe rx only 16 fl oz (473 ml) prugen ® pharmaceuticals principal display panel - 473 ml bottle box