Diflorasone Diacetate Oint (Page 2 of 2)

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 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

carton
(click image for full-size original)
tube
(click image for full-size original)

DIFLORASONE DIACETATE OINT diflorasone diacetate ointment ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70512-031
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIFLORASONE DIACETATE (DIFLORASONE) DIFLORASONE DIACETATE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70512-031-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (70512-031-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210753 02/04/2019
Labeler — Sola Pharmaceuticals (080121345)
Establishment
Name Address ID/FEI Operations
Teligent Pharma, Inc. 011036910 manufacture (70512-031)

Revised: 01/2021 Sola Pharmaceuticals

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