Sodium Sulfacetamide 10 Sulfur 2 Cream
Sulfacetamide Sodium And Sulfur
Acella Pharmaceuticals, Llc
Human Prescription Drug
NDC 42192-150Sodium Sulfacetamide 10 Sulfur 2 Cream 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 Sulfur 2 Cream is 42192-150. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Sodium Sulfacetamide 10 Sulfur 2 Cream drug includes Sulfacetamide Sodium - 100 mg/g Sulfur - 20 mg/g . The currest status of Sodium Sulfacetamide 10 Sulfur 2 Cream drug is Active.
Drug Information:
| Drug NDC: | 42192-150 |
| 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 Sulfur 2 Cream |
| 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: | Cream |
| 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 - 20 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: | 21 Aug, 2014 |
| 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: | Acella Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1000731
|
| 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 |
|---|
| 42192-150-02 | 57 g in 1 TUBE (42192-150-02) | 21 Aug, 2014 | 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 sulfur 2 cream sulfacetamide sodium and sulfur butylated hydroxytoluene polyoxyl 20 cetostearyl ether cetostearyl alcohol cetyl alcohol edetate disodium ethylhexyl palmitate ethylparaben glyceryl monostearate methylparaben phenoxyethanol propylene glycol propylparaben water sodium thiosulfate xanthan gum sulfacetamide sodium sulfacetamide sulfur sulfur
Indications and Usage:
Indications: sodium sulfacetamide 10% sulfur 2% cream is 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.
General Precautions:
For external use only. keep away from eyes. keep out of reach of children. keep container tightly closed. 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: cleanse skin thoroughly before application. apply a thin layer to affected areas 1-3 times daily or as directed by a physician. to minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.
Contraindications:
Contraindications: sodium sulfacetamide 10% sulfur 2% cream is contraindicated foruse by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sodium sulfacetamide 10% sulfur 2% cream 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 sodium sulfacetamide 10% sulfur 2% cream. it is not known whether sodium sulfacetamide 10% sulfur 2% cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfacetamide 10% sulfur 2% cream 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 gram of sodium sulfacetamide 10% sulfur 2% cream contains 100 mg of sodium sulfacetamide and 20 mg of sulfur in a base containing bht, ceteareth-20, cetearyl alcohol, cetyl alcohol,disodium edta, ethylhexyl palmitate, ethylparaben, fragrance, glyceryl monostearate se, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, sodium thiosulfate and xanthan gum. chemical structure
Clinical Pharmacology:
Clinical pharmacology: sodium sulfacetamide exhibits antibacterial activity. it is believed to block bacterial growth by acting as a competitive antagonist of para-aminobenzoic acid (paba). while absorption through intact skin has not been determined for sodium sulfacetamide, it is estimated that 1% of topically applied sulfur is absorbed. although the exact mode of the keralytic activity of sulfur is unknown, it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. in combination with sulfacetamide, sulfur has been reported to inhibit p. acnes , thereby reducing the 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: sodium sulfacetamide 10% sulfur 2% cream is available in 2 oz (57 g) tubes, ndc 42192-150-02. store at 20° - 25°c (68° - 77°f); excursions permitted to 15° - 30°c (59° - 86°f) [see usp controlled room temperature] keep this and all medications out of the reach of children. all prescription substitutions using this product shall be made subject to state and federal statutes as applicable. note: this is not an orange book product and has not been subjected to fda therapeutic equivalency or other equivalency testing. 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 ingredients and chemical formulation information provided herein.
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 - 57 g tube label ndc 42192-150-02 rx only sulfacetamide sodium 10% sulfur 2% cream net wt. 2 oz (57 g) acella pharmaceuticals, llc principal display panel - 170.3 g bottle label