Label: SYNALAR- fluocinolone acetonide cream
SYNALAR- fluocinolone acetonide kit

  • NDC Code(s): 43538-900-12, 43538-900-99, 43538-901-12
  • Packager: Medimetriks Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 29, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    for initiation of therapy in inflammatory dermatoses.
    Rx Only

  • DESCRIPTION

    SYNALAR® (fluocinolone acetonide) Cream 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)]-,(6α,11β,16α)-. It has the following chemical structure:

    Chemical Structure

    SYNALAR® Cream contains fluocinolone acetonide 0.25 mg/g in a water-washable aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid, edetate disodium, methylparaben and propylparaben (preservatives), mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, simethicone, stearyl alcohol, water (purified) and white beeswax.

  • 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

    SYNALAR® Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.

  • CONTRAINDICATIONS

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

  • PRECAUTIONS

    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:

    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 that 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:

     
    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 corticosteroidinduced hypothalmic-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 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 skin
    Itching Acneiform eruptions Secondary infection
    Irritation Hypopigmentation Skin atrophy
    Dryness Perioral dermatitis Striae
    Folliculitis Allergic contact dermatitis Miliaria
  • OVERDOSAGE

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

  • DOSAGE AND ADMINISTRATION

    SYNALAR® Cream is generally applied to the affected area as a 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 exercised 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

    SYNALAR® (fluocinolone acetonide) Cream 0.025% is supplied in

     
    60 g Tube – NDC 43538-900-60
     
    120 g Tube – NDC 43538-900-12

    STORAGE

    Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    383 Route 46 West, Fairfield, NJ 07004-2402 USA
    www.medimetriks.com

    Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310

    IP027-R2
    Rev. 11/16

  • PRINCIPAL DISPLAY PANEL - 120 g Tube Carton

    Rx Only

    NDC 43538-900-12

    SYNALAR®
    (fluocinolone acetonide)
    Cream, 0.025%

    For Topical Use Only
    Not For Ophthalmic Use

    120 g

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    PRINCIPAL DISPLAY PANEL - 120 g Tube Carton
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC 43538-901-12

    For Topical Use Only
    Not For Ophthalmic Use

    120 g

    Rx Only

    SYNALAR®
    (fluocinolone acetonide)
    Cream, 0.025%

    Cream KIT

    KIT CONTAINS:

    1 - SYNALAR®
    (fluocinolone acetonide)
    Cream, 0.025%
    120 g Tube

    1 - Keradan® Cream
    Net wt. 9 oz. (255 g) Tube

    MEDIMETRIKS
    PHARMACEUTICALS, INC.

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    SYNALAR 
    fluocinolone acetonide cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M) fluocinolone acetonide0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cetyl alcohol (UNII: 936JST6JCN)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    edetate disodium (UNII: 7FLD91C86K)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    mineral oil (UNII: T5L8T28FGP)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    propylene glycol (UNII: 6DC9Q167V3)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    water (UNII: 059QF0KO0R)  
    white wax (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-900-996 in 1 CARTON09/27/2012
    13 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:43538-900-121 in 1 CARTON09/27/2012
    2120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01278709/27/2012
    SYNALAR 
    fluocinolone acetonide kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-901
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43538-901-121 in 1 CARTON12/15/2012
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 120 g
    Part 21 TUBE 255 g
    Part 1 of 2
    SYNALAR  
    fluocinolone acetonide cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M) fluocinolone acetonide0.25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cetyl alcohol (UNII: 936JST6JCN)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    edetate disodium (UNII: 7FLD91C86K)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    mineral oil (UNII: T5L8T28FGP)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    propylene glycol (UNII: 6DC9Q167V3)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    water (UNII: 059QF0KO0R)  
    white wax (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01278712/15/2012
    Part 2 of 2
    KERADAN 
    moisturizing cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRwater (UNII: 059QF0KO0R)  
    INGRcetostearyl alcohol (UNII: 2DMT128M1S)  
    INGRmedium-chain triglycerides (UNII: C9H2L21V7U)  
    INGRglycerin (UNII: PDC6A3C0OX)  
    INGRcetyl alcohol (UNII: 936JST6JCN)  
    INGRpetrolatum (UNII: 4T6H12BN9U)  
    INGRpolyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    INGRcaprylyl trisiloxane (UNII: Q95M2P1KJL)  
    INGRcyclomethicone 5 (UNII: 0THT5PCI0R)  
    INGRcyclomethicone 4 (UNII: CZ227117JE)  
    INGRstearic acid (UNII: 4ELV7Z65AP)  
    INGRparaffin (UNII: I9O0E3H2ZE)  
    INGRpolysorbate 20 (UNII: 7T1F30V5YH)  
    INGRphenoxyethanol (UNII: HIE492ZZ3T)  
    INGRxanthan gum (UNII: TTV12P4NEE)  
    INGRcholesterol (UNII: 97C5T2UQ7J)  
    INGRallantoin (UNII: 344S277G0Z)  
    INGRyellow wax (UNII: 2ZA36H0S2V)  
    INGRmethylparaben (UNII: A2I8C7HI9T)  
    INGRlinoleic acid (UNII: 9KJL21T0QJ)  
    INGRtrolamine (UNII: 9O3K93S3TK)  
    INGRedetate disodium (UNII: 7FLD91C86K)  
    INGRsqualane (UNII: GW89575KF9)  
    INGR.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    INGRmicrocrystalline wax (UNII: XOF597Q3KY)  
    INGRolive oil (UNII: 6UYK2W1W1E)  
    INGRaluminum acetate (UNII: 80EHD8I43D)  
    INGRaluminum sulfate (UNII: 34S289N54E)  
    INGRcalcium acetate (UNII: Y882YXF34X)  
    INGRsodium lauroyl lactylate (UNII: 7243K85WFO)  
    INGRlinolenic acid (UNII: 0RBV727H71)  
    INGRhyaluronate sodium (UNII: YSE9PPT4TH)  
    INGRceramide 3 (UNII: 4370DF050B)  
    INGRceramide 6 II (UNII: F1X8L2B00J)  
    INGRtocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1255 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01278712/15/2012
    Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Teligent Inc011036910MANUFACTURE(43538-900, 43538-901)