INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE Fluocinolone Acetonide Cream, USP is indicated for the relief of the inflammatory and pruritic mani-festations of corticosteriod-responsive dermatoses.

OVERDOSAGE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 0713-0709-15Fluocinolone Acetonide Cream,USP 0.025%15 gRx onlyFOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.Cosette Pharmaceuticals, Inc.NDC 0713-0709-60Fluocinolone Acetonide Cream,USP 0.025%60 gRx onlyFOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.Cosette Pharmaceuticals, Inc.. carton 15 g. tube 15 g. carton 60 g. tube 60 g.

PRECAUTIONS SECTION.

PRECAUTIONS GeneralSystemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushings 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 large dose of potent topical steroid applied to large surface area or under an occlusive dressing should be evaluated periodi-cally 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 substi-tute 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 favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.Information for the PatientPatients 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 that 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 child being treated in the diaper area, as these garments may constitute occlusive dressings.Laboratory TestsThe following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation testCarcinogenesis, Mutagenesis, and Impairment of FertilityLong-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 CCorticosteroids are generally teratogenic in laboratory animals when adminis-tered 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 corti-costeroids 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 MothersIt 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 quanti-ties not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to nursing woman.Pediatric UsePediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushings syndrome than mature patients because of larger skin surface area to body weight ratio.HPA axis suppression, Cushings 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 stimula-tion. 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.. 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 that 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 child being treated in the diaper area, as these garments may constitute occlusive dressings.

STORAGE AND HANDLING SECTION.

STORAGE Store at room temperature 15-25C (59-77F); avoid freezing and excessive heat above 40C (104F).Manufactured by:Cosette Pharmaceuticals, Inc.111 Coolidge Street,South Plainfield, NJ 070808-0709CP1Iss. 08/2019.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical cortico-steroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:Burning Hypertrichosis Maceration of the skinItching Acneiform eruptions Secondary infectionIrritation Hypopigmentation Skin atrophyDryness Perioral dermatitis StriaeFolliculitis Allergic contact dermatitis MiliariaTo report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY SECTION.

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 recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.PharmacokineticsThe 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 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with history of hypersensitivity to any of the components of the preparation.

DESCRIPTION SECTION.

DESCRIPTION Fluocinolone Acetonide Cream, USP 0.025% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6,11,16)-. It has the following chemical structure:Fluocinolone Acetonide Cream, USP contains fluocinolone acetonide 0.25 mg/g in water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, simethicone emulsion, stearyl alcohol, and white wax.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION Fluocinolone Acetonide Cream, USP is generally applied to the affected area as thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion.Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. Some plastic films may be flammable and due care should be exer-cised in their use. Similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation.If an infection develops, the use of the occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED SECTION.

HOW SUPPLIED Fluocinolone Acetonide Cream, USP, 0.025% is supplied as follows: 15 Tube NDC 0713-0709-15 60 Tube NDC 0713-0709-60.