NDC 0115-1707 Fluocinonide

NDC Product Code 0115-1707

NDC 0115-1707-58

Package Description: 1 TUBE in 1 CARTON > 60 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Fluocinonide with NDC 0115-1707 is a product labeled by Impax Generics. The generic name of Fluocinonide is . The product's dosage form is and is administered via form.

Labeler Name: Impax Generics

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Impax Generics
Labeler Code: 0115
Start Marketing Date: 03-21-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Fluocinolone Topical

Fluocinolone Topical is pronounced as (floo oh sin' oh lone)

Why is fluocinolone topical medication prescribed?
Fluocinolone is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions.This medication is sometimes presc...
[Read More]
Fluocinonide Topical

Fluocinonide Topical is pronounced as (floo oh sin' oh nide)
Why is fluocinonide topical medication prescribed?
Fluocinonide is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions.This medication is sometimes presc...
[Read More]

* Please review the disclaimer below.

Fluocinonide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Fluocinonide Cream, USP 0.05% (Emulsified Base) is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α ,11β,16α )-. It has the following chemical structure:               Mol. Formula: C26H32F2O7                         Mol. Wt: 494.53                                                  Fluocinonide Cream, USP 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol.

Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications And Usage

Fluocinonide Cream USP, 0.05% (Emulsified Base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Fluocinonide Cream, USP 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS - Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information For The Patient

  • Patients using topical corticosteroids should receive the following information and instructions:This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.Patients should be advised not to use this medication for any disorder other than for which it was prescribed.The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions, especially under occlusive dressing.Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:                          Urinary free cortisol test                          ACTH stimulation test

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamicpituitary- adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:Burning HypertrichosisMaceration of the Skin      ItchingAcneiform EruptionsSecondary InfectionIrritationHypopigmentationSkin AtrophyDrynessPerioral DermatitisStriae  Folliculitis            Allergic Contact Dermatitis     Miliaria To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Dosage And Administration

Fluocinonide Cream, USP 0.05% (Emulsified Base) is generally applied to the affected area as a thin film from two to four times daily, as needed. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How Supplied

Fluocinonide Cream, USP 0.05% (Emulsified Base) is supplied in 15 g (NDC 0115-1705-52), 30 g (NDC 0115-1706-45) and 60 g (NDC 0115-1707-58) Tubes.Store at controlled room temperature 15°-30°C (59°-86°F). Do not refrigerate.Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080Distributed by: Impax GenericsHayward, CA 945441933-01GW 7140Issued 08/20168-0664IMLNC1

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