NDC 70512-034 Fluocinonide Gel

Fluocinonide Gel

NDC Product Code 70512-034

NDC Product Information

Fluocinonide Gel with NDC 70512-034 is a a human prescription drug product labeled by Kbs Solutions. The generic name of Fluocinonide Gel is fluocinonide gel. The product's dosage form is gel and is administered via topical form.

Labeler Name: Kbs Solutions

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Prescription Drug 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.


Fluocinonide Gel Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FLUOCINONIDE .5 mg/g

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.

  • WATER (UNII: 059QF0KO0R)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)

Product Labeler Information

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

Labeler Name: Kbs Solutions
Labeler Code: 70512
FDA Application Number: ANDA209030 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-04-2019 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: 12-31-2020 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: N 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.

Fluocinonide Gel Product Label Images

Fluocinonide Gel 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 Gel USP, 0.05% 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)]-,(6a,11b,16a)-. It has the following chemical structure:

Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base

consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to

adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and

completely water miscible.

In the Fluocinonide Gel USP, 0.05% formulation, the active ingredient is totally in solution.

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.

Indication And Usage

Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations

of corticosteroid-responsive dermatoses.

Contraindication

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of

the components of the preparations.

Precaution

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 Us e). 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:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact

with the eyes.

2. Patients should be advised not to use this medication for any disorder other than for which it was

prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive

unless directed by the physician.

4. Patients should report any signs of local adverse reactions, especially under occlusive dressing.

5. 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:

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 hypothalamic-

pituitary-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

Urinary free cortisol test

ACTH stimulation test

occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate

decreasing order of occurrence:
Burning

Itching

Irritation

Dryness

Folliculitis
Hypertrichosis

Acneiform Eruptions

Hypopigmentation

Perioral Dermatitis

Allergic Contact Dermatitis

Maceration of the Skin

Secondary Infection

Skin Atrophy
StriaeMiliari
To report SUSPECTED ADVERSE REACTIONS contact Teligent Pharma, Inc. at 856-697-1441 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 Gel USP, 0.05% is generally applied to the affected area as a thin film from two to four

times daily depending on the severity of the condition.

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 Gel USP, 0.05% is supplied in 15 g (NDC 52565-054-15), 30 g (NDC 52565-054-30) and

60 g (NDC 52565-054-60) tubes.

Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature].

Manufactured by:

Teligent Pharma, Inc.

Buena, NJ 08310

Revised: 04/2017

Package Label

NDC 52565-054-15

Fluocinonide Gel USP, 0.05%

Net Wt 15 g

Rx Only

FOR EXTERNAL USE ONLY.

NOT FOR OPHTHALMIC USE.

* Please review the disclaimer below.

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