Ovace
Sulfacetamide Sodium
Mission Pharmacal Company
Human Prescription Drug
NDC 0178-0499Ovace also known as Sulfacetamide Sodium is a human prescription drug labeled by 'Mission Pharmacal Company'. National Drug Code (NDC) number for Ovace is 0178-0499. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Ovace drug includes Sulfacetamide Sodium - 100 mg/mL . The currest status of Ovace drug is Active.
Drug Information:
| Drug NDC: | 0178-0499 |
| 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: | Ovace |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mission Pharmacal Company |
| 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: | 15 Sep, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 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: | Mission Pharmacal Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1006107
1006110
|
| 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 |
|---|
| 0178-0499-06 | 180 mL in 1 BOTTLE, PLASTIC (0178-0499-06) | 15 Sep, 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:
Ovace sulfacetamide sodium propylene glycol citric acid monohydrate glycol stearate edetate sodium methylparaben propylparaben peg-150 pentaerythrityl tetrastearate water peg-6 caprylic/capric glycerides peg-60 almond glycerides coco diethanolamide sodium chloride sodium laureth sulfate cocamidopropyl betaine sulfacetamide sodium sulfacetamide light yellow
Indications and Usage:
Indications: this product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis 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:
Warnings: sulfonamides are known to cause stevens-johnson syndrome in hypersensitive individuals. stevens-johnson syndrome also has been reported following the use of sodium sulfacetamide topically. cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. in one of these cases, there was a fatal outcome. keep out of the reach of children.
Dosage and Administration:
Dosage and administration: seborrheic dermatitis including seborrhea sicca - wash affected areas twice daily (morning and evening) 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 working into a full lather, rinse thoroughly, pat dry and repeat after 10 to 20 seconds. rinsing with plain water will remove any excess medication. repeat application as described above for 8 to 10 days or as directed by your physician. lf skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. regular shampooing following the use of this product is not necessary, but the hair should be shampooed at least once a week. as the condition subsides, the interval between applications may be lengthened. applications once or twice weekly or every other week may prevent recurrence. should the condition recur after stopping therapy, the application of this product shoul
Read more...d be reinitiated as at the beginning of treatment. secondary cutaneous bacterial infections - wash affected areas twice daily (morning and evening) 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 to 20 seconds working into a full lather, rinse thoroughly and pat dry. rinsing with plain water will remove any excess medication. repeat application as described above for 8 to 10 days or as directed by your physician. if skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently.
Contraindications:
Contraindications: this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. this product is not to be used by patients with kidney disease.
Adverse Reactions:
Adverse reactions: reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. the following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of stevens-johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see warnings).
Overdosage:
Overdosage: the oral ld 50 of sulfacetamide in mice is 16.5 g/kg. in the event of overdosage, emergency treatment should be started immediately. manifestations: overdosage may cause nausea and vomiting. large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. for treatment, contact your local poison control center or your doctor.
Description:
Description: each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium edta, fragrance, methylparaben, peg-150 pentaerythrityl tetrastearate (and) aqua (and) peg-6 caprylic/capric glycerides, peg-60 almond triglycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide dea (and) cocamidopropyl betaine (and) glycol stearate. sodium sulfacetamide is a sulfonamide with antibacterial activity. sodium sulfacetamide is c 8 h 9 n 2 nao 3 s·h 2 o with molecular weight of 254.24. chemically, sodium sulfacetamide is n-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. the structural formula is: sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. it is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether. structure
Clinical Pharmacology:
Clinical pharmacology: sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive gram-positive and gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. it acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. there is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. however, significant absorption of sodium sulfacetamide through the skin has been reported. the following in vitro data is available but the clinical significance is unknown. organisms that show susceptibility to sodium sulfacetamide are: streptococci, staphylococci, e. coli, klebsiella pneumoniae, pseudomonas pyocyanea, salmonella species, proteus vulgaris, nocardia and actinomyces.
How Supplied:
How supplied: this product is supplied in the following size(s): 6 fl. oz. (180 ml) bottles, ndc 0178-0499-06 12 fl. oz. (355 ml) bottles, ndc 0178-0499-12 16 fl. oz. (480 ml) bottles, ndc 0178-0499-16 to report a serious adverse event or obtain product information, call 1-800-298-1087. manufactured for: mission pharmacal company san antonio, tx 78230 1355 825243
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