Sodium Sulfacetamide - Sulfur Cleansing Pads
Sodium Sulfacetamide, Sulfur
Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-113Sodium Sulfacetamide - Sulfur Cleansing Pads also known as Sodium Sulfacetamide, Sulfur is a human prescription drug labeled by 'Acella Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Sulfacetamide - Sulfur Cleansing Pads is 42192-113. This drug is available in dosage form of Swab. The names of the active, medicinal ingredients in Sodium Sulfacetamide - Sulfur Cleansing Pads drug includes Sulfacetamide Sodium - 10 g/100g Sulfur - 4 g/100g . The currest status of Sodium Sulfacetamide - Sulfur Cleansing Pads drug is Active.
Drug Information:
| Drug NDC: | 42192-113 |
| 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 - Sulfur Cleansing Pads |
| 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, 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: | Swab |
| 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 g/100g
SULFUR - 4 g/100g
|
| 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: | 30 Jul, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | 1000946
|
| 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 |
|---|
| 42192-113-60 | 60 POUCH in 1 BOX (42192-113-60) / 3.7 g in 1 POUCH | 30 Jul, 2009 | 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 - sulfur cleansing pads sodium sulfacetamide, sulfur water aloe vera leaf sodium thiosulfate edetate disodium magnesium aluminum silicate xanthan gum sulfacetamide sodium sulfacetamide sulfur sulfur
Indications and Usage:
Indications: sodium sulfacetamide 10% - sulfur 4% cleansing pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Warnings:
Warnings: although rare, sensitivity to sodium sulfacetaminde 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.
Dosage and Administration:
Dosage and administration: wash affected area(s) with cleansing pad once or twice dialy, or as directed by your physician. wet area(s) with water. wet pad with a little water and work into a full lather. cleanse area(s) with pad for 10-20 seconds, avoiding eyes. rinse thoroughly and pat dry. discard pad. do not flush.
Contraindications:
Contraindications: sodium sulfacetamide 10% - sulfur 4% cleansing pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or ony other component of this preparation. sodium sulfacetamide 10% - sulfur 4% cleansing pads are 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: pregnancy category c. animal reproduction studies have not been conducted with sodium sulfacetamide 10% - sulfur 4% cleansing pads. it is not known whether sodium sulfacetamide 10% - sulfur 4% cleansing pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfacetamide 10% - sulfur 4% cleansing pads 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 while sulfur acts as a keratolytic agent. chemically sodium sulfacetamide is n-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. the structural formula is: each pad of sodium sulfacetamide 10% - sulfur 4% cleansing pads are coated with a cleanser-based formulation. each gram of this cleanser-based formulation contains 100 mg of sodium sulfacetamide and 40 mg of sulfur. the cleanser base consists of: purified water, sodium cocoyl isethionate disodium oleamido mea sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and peg 100 stearate methyl paraben, propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosulfate, disodium edta, magnesium aluminum silicate, xanthan gum, sodium methyl cocoyl taurate, white petrolatum. productformula
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 not known, 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 4% cleansing pads are available in boxes of 60 cloths (3.7 g), (ndc 42192-113-60). store at controlled room temperature, 15° - 25° (59° - 77°f). all prescription substitutions 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 testing. 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, incipients, inactive ingredients and chemical formulation information provided herein.
Package Label Principal Display Panel:
Sodum sulfacetamide 10%- sulfur 4% cleansing pads in a vehicle containing green tea and aloe rx only 60 cleansing pads net wegith 3.7g each acella pharmaceuticals directions: wash affected areas with sodium sulfacetamide 10% - sulfur 4% once or twice daily or as direted by your physician. 1. wet affected areas with water 2. wet sodium sulfacetamide 10% - sulfur 4% cleansing pad with water and work into a full lather. 3. cleanse face with sodium sulfacetamide 10% - sulfur 4% for 10 -20 seconds, avoiding eyes 4. rinse thoroughly and pat dry 5. discard pad. do not flush. warnings for external use only. keep out of reach of children. avoid contact with eyes. indications: for the typical control of acne vulgaris and seborrheic dermatitis. see package insert for full prescribing information. contraindications: sodium sulfacetamide 10% - sulfur 4% cleansing pads are contraindicated for use in patients having known hypersensitivity to sulfonamides, sulfur or anyother component of the preparation. sodium sulfacetamide 10% - sulfur 4% cleansing pads are not to be used by patients with kidney disease. contents: sodium sulfacetamide 10% - sulfur 4%. other ingredients: purified water, sodium cocoyl isethionate, disodium oleamido mea sulfosuccinate, green tea extract, cetyl alcohol, stearyl alcohol, glycerol stearate and peg 100 stearate methyl paraben, propyl paraben, butylated hydroxytoluene, aloe vera gel, sodium thiosufate, disodium edta, magnesium aluminum siliate, xanthan gum, sodium methyl cocoyl l-taurate, white petrolatum acella pharmaceuticals store at 15 degrees to 25 degrees c or 59-77 degrees f) all prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. note. this is not an orange book product. no representation is made as to generic status or bioequivalency. please see package insert for more information. manufactured for: acella pharmaceuticals, llc 9005 westside parkway alpharetta, ga 30009 1-800-541-4802
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