NDC 0115-1706 Fluocinonide

Product Information

Product Packages

NDC 0115-1706-45

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

Price per Unit: $1.54113 per GM

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

Product Details

Fluocinonide is product labeled by Impax Generics. The product's dosage form is and is administered via form.


What are Fluocinonide Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • FLUOCINONIDE (UNII: 2W4A77YPAN)
  • FLUOCINONIDE (UNII: 2W4A77YPAN) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)


* Please review the disclaimer below.

Patient Education

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 Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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: C26H32F2O          
              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 Infection
IrritationHypopigmentationSkin Atrophy
DrynessPerioral 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 07080

Distributed by: 
Impax Generics
Hayward, CA 94544
1933-01

GW 7140
Issued 08/2016
8-0664IMLNC1


Principal Display Panel - 0.05%, 15 G Cream Carton



NDC 0115-1705-52

15 g


Principal Display Panel - 0.05%, 30 G Cream Carton



NDC 0115-1706-45

30 g


Principal Display Panel - 0.05%, 60 G Cream Carton



NDC 0115-1707-58

60 g


* Please review the disclaimer below.