Sodium Sulfacetamide
Oceanside Pharmaceuticals
Human Prescription Drug
NDC 68682-010Sodium Sulfacetamide is a human prescription drug labeled by 'Oceanside Pharmaceuticals'. National Drug Code (NDC) number for Sodium Sulfacetamide is 68682-010. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Sodium Sulfacetamide drug includes Sulfacetamide Sodium - 100 mg/mL . The currest status of Sodium Sulfacetamide drug is Active.
Drug Information:
| Drug NDC: | 68682-010 |
| 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 |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Oceanside Pharmaceuticals |
| 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 - 100 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: | NDA AUTHORIZED GENERIC |
| 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 Dec, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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. |
| Application Number: | NDA019931 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Oceanside Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1006688
|
| 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
|
| 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 |
|---|
| 68682-010-04 | 1 BOTTLE, PLASTIC in 1 CARTON (68682-010-04) / 118 mL in 1 BOTTLE, PLASTIC | 18 Dec, 2015 | 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 sodium sulfacetamide sulfacetamide sodium sulfacetamide edetic acid hydroxyethyl cellulose (2000 mpa.s at 1%) polyethylene glycol 400 lauric diethanolamide methylparaben sodium chloride sodium metabisulfite water xanthan gum
Indications and Usage:
Indications sodium sulfacetamide lotion is indicated in the topical treatment of acne vulgaris .
Warnings:
Warnings fatalities have occurred, although rarely, due to severe reactions to sulfonamides including 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. sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. at the first sign of hypersensitivity, skin rash, or other reactions, discontinue use of this preparation (see adverse reactions ). sodium sulfacetamide lotion contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. the overall prevalence of sulfite sensitivity in the general population is unknown and probably low. sulfite sensitivity is seen more frequently in asthmatic than in
Read more... non-asthmatic people (see contraindications ).
General Precautions:
General for external use only. keep away from eyes. 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. hypersensitivity reactions may occur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. sodium sulfacetamide can cause reddening and scaling of the skin. particular caution should be employed if areas of involved skin to be treated are denuded or abraded. keep out of reach of children.
Dosage and Administration:
Dosage and administration apply a thin film to affected areas twice daily.
Contraindications:
Contraindications sodium sulfacetamide lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see warnings ).
Adverse Reactions:
Adverse reactions in controlled clinical trials for the management of acne vulgaris , the occurrence of adverse reactions associated with the use of sodium sulfacetamide lotion was infrequent and restricted to local events. the total incidence of adverse reactions reported in these studies was less than 2%. only one of 105 patients treated with sodium sulfacetamide lotion had adverse reactions of erythema, itching, and edema. it has been reported that sodium sulfacetamide may cause local irritation, stinging, and burning. while the irritation may be transient, occasionally the use of medication has to be discontinued. to report suspected adverse reactions, contact oceanside pharmaceuticals at 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Use in Pregnancy:
Animal reproduction studies have not been conducted with sodium sulfacetamide lotion. it is also not known whether sodium sulfacetamide lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfacetamide lotion should be given to a pregnant woman only if clearly needed. kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamide. there are no adequate and well-controlled studies of sodium sulfacetamide lotion in pregnant women, and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients under the age of 12 have not been established.
Description:
Description each ml of sodium sulfacetamide lotion, 10% contains 100 mg of sodium sulfacetamide in a vehicle consisting of edetic acid, hydroxyethyl cellulose, lauramide dea, methylparaben, peg-400 monolaurate, propylene glycol, purified water, silicone emulsion, sodium chloride, sodium metabisulfite, and xanthan gum. sodium sulfacetamide is a sulfonamide with antibacterial activity. chemically, sodium sulfacetamide is n' -[(4-amino phenyl) sulfonyl] - acetamide, monosodium salt, monohydrate. the structural formula is: chemical structure
Clinical Pharmacology:
Clinical pharmacology the most widely accepted mechanism of action of sulfonamides is the woods-fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (paba) utilization, an essential component for bacterial growth. while absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. the biological half-life has been reported to be between 7 to 13 hours. the pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in sodium sulfacetamide lotion was evaluated in adult subjects (n=14) with acne vulgaris . the subjects applied sodium sulfacetamide lotion to their face, back, chest, and shoulders every 12 hours for 28 days. the percentage of the applied dose of sodium sulfacetamide lotion excreted in the ur
Read more...ine as sulfacetamide plus sulfanilamide ranged from 0.08 to 0.33%.
Pharmacokinetics:
The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in sodium sulfacetamide lotion was evaluated in adult subjects (n=14) with acne vulgaris . the subjects applied sodium sulfacetamide lotion to their face, back, chest, and shoulders every 12 hours for 28 days. the percentage of the applied dose of sodium sulfacetamide lotion excreted in the urine as sulfacetamide plus sulfanilamide ranged from 0.08 to 0.33%.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility long-term studies in animals have not been performed to evaluate carcinogenic potential.
How Supplied:
How supplied 4 fl oz (118 ml) bottles ndc 68682-010-04 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. shake well before using. keep tightly closed.
Package Label Principal Display Panel:
Principal display panel - 118 ml bottle carton ndc 68682-010-04 rx only sodium sulfacetamide lotion, 10% for topical use only shake well before using one 4 fl oz (118 ml) bottle oceanside pharmaceuticals carton.jpg