NDC 70512-031 Diflorasone Diacetate Oint

Diflorasone Diacetate Ointment

NDC Product Code 70512-031

NDC Code: 70512-031

Proprietary Name: Diflorasone Diacetate Oint What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Diflorasone Diacetate Ointment What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 70512 - Sola Pharmaceuticals
    • 70512-031 - Diflorasone Diacetate Oint

NDC 70512-031-60

Package Description: 1 TUBE in 1 CARTON > 60 g in 1 TUBE

NDC Product Information

Diflorasone Diacetate Oint with NDC 70512-031 is a a human prescription drug product labeled by Sola Pharmaceuticals. The generic name of Diflorasone Diacetate Oint is diflorasone diacetate ointment. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Sola Pharmaceuticals

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.


Diflorasone Diacetate Oint 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.

  • DIFLORASONE DIACETATE .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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

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: Sola Pharmaceuticals
Labeler Code: 70512
FDA Application Number: ANDA210753 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.

Diflorasone Diacetate Oint Product Label Images

Diflorasone Diacetate Oint 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

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.
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. 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.

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.

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

prescribed.

3. Contact your healthcare provider if you experience blurred vision or other visual disturbances (see

WARNINGS).

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:

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.
Pregnancy
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

woman.
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.

Urinary free cortisol test

ACTH stimulation test
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

exposure.

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 www.fda.gov/medwatch.

Overdosage

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

(See PRECAUTIONS.)

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 15 gram (NDC52565-063-15), 30 gram

(NDC 52565-063-30) and 60 gram (NDC 52565-063-60) tubes.

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

Manufactured by:

Teligent Pharma, Inc.

Buena, NJ 08310

Revised: 04/2018

PRINCIPAL DISPLAY PANEL

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