Drugplain

Diflorasone Diacetate .5 mg/g

Diflorasone Diacetate · CREAM · Sun Pharmaceutical Industries, Inc.

No Recall History
Plain English

Diflorasone diacetate cream is a prescription topical medication used to reduce inflammation and itching associated with various skin conditions. It belongs to a class of anti-inflammatory steroids that are applied directly to the affected area of skin.

Key Facts

Brand Name
Diflorasone Diacetate
Generic Name
Diflorasone Diacetate
NDC Code (Product)
51672-1296
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
.5 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA075508
Marketing Start
04/24/2000

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

psoriasis11 reports
pyrexia11 reports
pruritus10 reports
febrile neutropenia7 reports
nausea7 reports
rash7 reports
drug ineffective6 reports
pain6 reports
vomiting6 reports
anaemia5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 cream is a prescription topical medication used to reduce inflammation and itching associated with various skin conditions. It belongs to a class of anti-inflammatory steroids that are applied directly to the affected area of skin.

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 51672-1296, listed by Sun Pharmaceutical Industries, Inc..

Product NDC

51672-1296

Package NDC

51672-1296-1

Other Diflorasone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)