Diflorasone Diacetate
Diflorasone Diacetate is an FDA drug label for the active ingredient DIFLORASONE DIACETATE manufactured by Rising Pharma Holdings, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230502.
- Generic name
- DIFLORASONE DIACETATE
- Manufacturer
- Rising Pharma Holdings, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 64980-124
- Application
- ANDA207440
- Label effective
- 20230502
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.
Warnings
Not available.
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.