Exact-rx Sodium Sulfacetamide And Sulfer 10%/5% Cleanser
Sodium Sulfacetamide, Sulfur
Exact-rx, Inc.
Human Prescription Drug
NDC 42808-113Exact-rx Sodium Sulfacetamide And Sulfer 10%/5% Cleanser also known as Sodium Sulfacetamide, Sulfur is a human prescription drug labeled by 'Exact-rx, Inc.'. National Drug Code (NDC) number for Exact-rx Sodium Sulfacetamide And Sulfer 10%/5% Cleanser is 42808-113. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Exact-rx Sodium Sulfacetamide And Sulfer 10%/5% Cleanser drug includes Sulfacetamide Sodium - 100 mg/g Sulfur - 50 mg/g . The currest status of Exact-rx Sodium Sulfacetamide And Sulfer 10%/5% Cleanser drug is Active.
Drug Information:
| Drug NDC: | 42808-113 |
| 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: | Exact-rx Sodium Sulfacetamide And Sulfer 10%/5% Cleanser |
| 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: | Exact-rx, 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 - 100 mg/g
SULFUR - 50 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: | 01 Aug, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 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 |
|---|
| 42808-113-06 | 170 g in 1 BOTTLE (42808-113-06) | 01 Aug, 2011 | N/A | No |
| 42808-113-12 | 340 g in 1 BOTTLE (42808-113-12) | 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 and sulfer 10%/5% cleanser sodium sulfacetamide, sulfur sulfacetamide sodium sulfacetamide ammonium lauryl sulfate butylated hydroxytoluene cetyl alcohol cocamidopropyl betaine edetate disodium anhydrous glycerin glyceryl stearate se guar gum methylparaben peg-100 stearate propylene glycol propylparaben water sodium thiosulfate stearyl alcohol triacetin sulfur sulfur
Indications and Usage:
Indications : sodium sulfacetemide 10% and sulfer 5% cleanser is indicated for he topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
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 area once or twice daily, or as directed by your physician. avoid contat with eyes or mucous membranes. 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 cleanser off sooner or using less often. see package insert for complete product information .
Contraindications:
Contraindications : sodium sulfacetamide 10% & sulfer 5% cleanser is contraindicated in persons with know or suspected hypersensitivity to sulfonamides, sulfer or any other component of this preparation. sodium sulfacetamide 10% & sulfer %5% cleanser is not to be used by patients with kidney disease. caution : if redness or irritaiton occurs, discontinue use.
Description:
Manufactured in the u.s.a. for exact-rx, inc., melville, ny 11747
Spl Patient Package Insert:
Sodium sulfacetamide 10% & sulfur 5% cleanser rx only 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% and sulfur 5% cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a cleanser containing butylated hydroxytoluene, cetyl alcohol, disodium edta, disodium oleamido mea-sulfosuccinate, glyceryl stearate, magnesium aluminum silicate, methylparaben, peg-100 stearate, petrolatum, propylene glycol, propylparaben, purified water, sodium cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate, stearyl alcohol, xanthan gum. clinical pharmacology : the most widely accepted mechanism of action of sulfonamides is the woods-fields theory which is based on the fact that sulfonamides act as competitive antagonists to para-aminoben
Read more...zoic 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. indications : sodium sulfacetamide 10% & sulfur 5% cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. contraindications : sodium sulfacetamide 10% & sulfur 5% cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sodium sulfacetamide 10% & sulfur 5% cleanser is not to be used by patients with kidney disease. warnings : although it is 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. in case of accidental ingestion contact a poison control center immediately. 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. 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. carcinogenesis, mutagenesis and impairment of fertility: long-term studies in animals have not been performed to evaluate carcinogenic potential. pregnancy: category c. animal reproduction studies have not been conducted with sodium sulfacetamide 10% & sulfur 5% cleanser. it is also not known whether sodium sulfacetamide 10% & sulfur 5% cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfacetamide 10% & sulfur 5% cleanser should be given to a pregnant woman only if clearly needed. nursing mothers : it is not known whether sodium sulfacetamide is excreted in the human milk following topical use of sodium sulfacetamide 10% & sulfur 5% cleanser. however, small amounts of orally administered sulfonamides have milk. in view of this and because many drugs are excreted in human milk, caution should be exercised when sodium sulfacetamide 10% & sulfur 5% cleanser is administered to a nursing woman. pediatric use : safety and effectiveness in children under the age of 12 have not been established. adverse reactions: although rare, sodium sulfacetamide may cause local irritation. call your doctor for medical advice about side effects. dosage and administration: wash affected areas once or twice daily, or as directed by your physician. avoid contact with eyes or mucous membranes. 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 cleanser off sooner or using less often. how supplied: sodium sulfacetamide 10% & sulfur 5% cleanser is available in a 6 oz (170 g) bottle, ndc 42808-113-06 and a 12 oz (340 g) bottle, ndc 42808-113-12. store at 20 to 25°c (68 to 77°f). see usp controlled room temperature. protect from freezing. manufactured in the u.s.a. for exact-rx, inc., melville, ny 11747 00-113-205-00 iss:01
Package Label Principal Display Panel:
113-12
113-16