Exact-rx Sodium Sulfacetamide Wash 10%
Sodium Sulfacetamide
Exact-rx, Inc.
Human Prescription Drug
NDC 42808-103Exact-rx Sodium Sulfacetamide Wash 10% also known as Sodium Sulfacetamide is a human prescription drug labeled by 'Exact-rx, Inc.'. National Drug Code (NDC) number for Exact-rx Sodium Sulfacetamide Wash 10% is 42808-103. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Exact-rx Sodium Sulfacetamide Wash 10% drug includes Sulfacetamide Sodium - 100 mg/mL . The currest status of Exact-rx Sodium Sulfacetamide Wash 10% drug is Active.
Drug Information:
| Drug NDC: | 42808-103 |
| 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: | Exact-rx Sodium Sulfacetamide Wash 10% |
| 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: | Exact-rx, 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/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 Aug, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Jun, 2026 |
| 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, 2024 |
| 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: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | |
| 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 |
|---|
| 42808-103-06 | 177 mL in 1 BOTTLE (42808-103-06) | 01 Aug, 2011 | N/A | No |
| 42808-103-12 | 354.8 mL in 1 BOTTLE (42808-103-12) | 01 Aug, 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:
Exact-rx sodium sulfacetamide wash 10% sodium sulfacetamide ammonium lauryl sulfate butylated hydroxytoluene cocamidopropyl betaine ceteareth-25 cetyl alcohol edetate disodium anhydrous glycerin guar gum methylparaben propylene glycol propylparaben water sodium thiosulfate stearyl alcohol triacetin sulfacetamide sodium sulfacetamide
Indications and Usage:
Indications : sodium sulfacetemide 10% wash is intended for topical application in the following scaling dermatoses: seborrheic dermatisis and seborrhea sicca (dandruff). it also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
Warnings:
For external use only. not for intravaginal or ophthalmic use. (keep away from eyes) .
Keep this and all medication out of reach of children . in case of accidental ingestion contact a poison control center immediately. keep container tightly closed.
Dosage and Administration:
Directions for use : wash affected areas twice daily (morning and evening) or as directed by your physician. rinse thoroughly and pat dry. see package insert for complete product information .
Contraindications:
Contraindications: sodium sulfacetamide 10% wash is contraindicated in persons with know or suspected hypersensitivity to sulfonamides.
Description:
Manufactured in the u.s.a. for exact-rx, inc., melville, ny 11747
Spl Patient Package Insert:
Sodium sulfacetamide 10% wash (sodium sulfacetamide 10%) rx only for external use only . not for ophthalmic use . description: each gram contains 100 mg of sodium sulfacetamide usp in a vehicle consisting of: ammonium lauryl sulfate, butylated hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium edta, glycerin, guar gum, methylparaben, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin. how supplied: sodium sulfacetamide wash 10% is available in a 6 fl oz (170 ml) bottle, ndc 42808-101-06, and in a 12 fl oz (354.8 ml) bottle, ndc 42808-101-12. manufactured in the u.s.a. for exact-rx, inc., melville, ny 11747 00-101-205-00 iss:12/16
Package Label Principal Display Panel:
103-06
103-12