Diflorasone Diacetate .5 mg/g
diflorasone diacetate · OINTMENT · Rising Pharma Holdings, Inc.
Diflorasone Diacetate is a ointment containing diflorasone diacetate at .5 mg/g, taken topical. Manufactured by Rising Pharma Holdings, Inc..
Key Facts
- Brand Name
- Diflorasone Diacetate
- Generic Name
- diflorasone diacetate
- NDC Code (Product)
64980-124- Manufacturer
- Rising Pharma Holdings, Inc.
- Strength
- .5 mg/g
- Dosage Form
- OINTMENT
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA207440
- Marketing Start
- 02/27/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
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. 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 initiated.
Contraindications
CONTRAINDICATIONS Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
ADVERSE REACTIONS The following local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: 1. Burning 2. Itching 3. Irritation 4. Dryness 5. Folliculitis 6. Hypertrichosis 7. Acneiform eruptions 8. Hypopigmentation 9. Perioral dermatitis 10. Allergic contact dermatitis 11. Maceration of the skin 12. Secondary infection 13. Skin atrophy 14. Striae 15. Miliaria To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Diflorasone Diacetate used for?
Diflorasone Diacetate contains diflorasone diacetate. It is a ointment taken topical. Consult your doctor for specific uses.
Is Diflorasone Diacetate a controlled substance?
Diflorasone Diacetate is not classified as a controlled substance by the DEA.
What is the generic name for Diflorasone Diacetate?
The generic name for Diflorasone Diacetate is diflorasone diacetate. There are 1 other brand versions of diflorasone diacetate.
What is the NDC code for Diflorasone Diacetate .5 mg/g?
The NDC (National Drug Code) for Diflorasone Diacetate .5 mg/g is 64980-124, listed by Rising Pharma Holdings, Inc..