Label: DIFLORASONE DIACETATE OINT- diflorasone diacetate ointment ointment

  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 12, 2021

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  • Description

    Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base.
    Chemically, diflorasone diacetate is 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-
    3,20-dione 17,21-diacetate. The structural formula is represented below:


    Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base of
    glyceryl monostearate, propylene glycol and white petrolatum.

  • Clinical Pharmacology

    Topical corticosteroids share anti-inflammatory, antipruritic 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.

    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. They 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

    Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of
    corticosteroid-responsive dermatoses.

  • Contraindications

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

  • Warnings

    Use of topical corticosteroids, including diflorasone diactate dintment may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts have been reported in postmarketing experience with the use of topical diflorasone diacetate products. Glaucoma, with possible damage to the optic nerve, and increased intraocular pressure have been reported in postmarketing experience with the use of topical dermal corticosteroids.

    Avoid contact of Diflorasone Diacetate Ointment with eyes. Advise patients to report any visual symptoms.

  • Precautions

    Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal
    (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some
    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
    Pediatric patients 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.
    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
    3. Contact your healthcare provider if you experience blurred vision or other visual disturbances (see
    4. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive
    unless directed by the physician.
    5. Patients should report any signs of local adverse reactions especially under occlusive dressing.
    6. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on an
    infant or 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, Impairment of Fertility
    Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect
    on fertility of topical corticosteroids.
    Diflorasone diacetate was not mutagenic in a micronucleus test in rats at intraperitoneal doses up to
    2400 mg/kg.

    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. Because many drugs are excreted in human
    milk, caution should be exercised when Diflorasone Diacetate Ointment is administered to a nursing

    Pediatric Use
    Safety and effectiveness of diflorasone diacetate ointment in pediatric patients have not been
    established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a
    greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.
    They are, therefore, also at greater risk of glucocorticosteroid insufficiency after withdrawal of
    treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been
    reported with inappropriate use of topical corticosteroids in pediatric patients.
    HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in
    pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric
    patients 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.

    Geriatric Use
    Clinical studies of diflorasone diacetate topical formulations did not include sufficient numbers of
    subjects aged 65 and over to determine whether they respond differently from younger subjects.

  • Adverse Reactions

    The following local adverse reactions have been identified from clinical trials or postmarketing
    surveillance. Because they are reported from a population from unknown size, it is not always possible
    to reliably estimate their frequency or establish a causal relationship to topical corticosteroids

    These adverse reactions may occur more frequently with the use of occlusive dressings or prolonged
    use of topical corticosteroids.

    Skin and Subcutaneous Tissue Disorders: burning, itching, irritation, dryness, folliculitis,
    hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis,
    maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

    Vision Disorders: cataract, glaucoma, central serous chorioretinopathy

    To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441,
    or FDA at 1-800-FDA-1088 or

  • Overdosage

    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.

  • Dosage and Administration

    Diflorasone diacetate ointment should be applied to the affected area as a thin film from one to three
    times daily depending on the severity or resistant nature of the condition.

    For topical us only. Avoid contact with eyes.

    Wash hands after each application.

    Do not use with occlusive dressings, unless directed by a physician (see PRECAUTIONS).

    If an infection develops, the use of occlusive dressings should be discontinued and appropriate
    antimicrobial therapy initiated.

  • How Supplied

    Diflorasone Diacetate Ointment USP, 0.05% is available in 60 gram (NDC 70512-031-60) tubes.

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

    Manufactured for:
    Sola Pharmaceuticals
    Baton Rouge, LA 70809
    Revised: 01/2019

  • Principal Display Panel

    60 g Tube Carton
    NDC 70512-031-60

    Diflorasone Diacetate
    Ointment USP, 0.05%

    For Topical Use Only
    Not For Ophthalmic Use
    Net Wt. 60 g Rx only

    Keep this and all medications out of the reach of children.

    Sola Pharmaceuticals


    diflorasone diacetate ointment ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70512-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    Product Characteristics
    FlavorImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-031-601 in 1 CARTON02/04/2019
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Sola Pharmaceuticals (080121345)
    NameAddressID/FEIBusiness Operations
    Teligent Pharma, Inc.011036910manufacture(70512-031)