Diflorasone Diacetate (Page 2 of 2)

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.

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.

HOW SUPPLIED

Diflorasone Diacetate Ointment USP, 0.05% is available in 15 gram (NDC 61748-350-15), 30 gram (NDC 61748-350-30) and 60 gram (NDC 61748-350-60) tubes.

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

Marketed by:
VersaPharm Inc. – An Akorn Company
Lake Forest, IL 60045
VersaPharm Logo

Manufactured by:
Ei LLC
Kannapolis, NC 28083

DFO00N
Rev. 09/2015

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 60 g Tube Label

NDC 61748-350-60

Diflorasone Diacetate
Ointment USP, 0.05%

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Keep this and all medications out of the reach of children.

Rx only

60 g

PRINCIPAL DISPLAY PANEL -- 60 g Tube Label
(click image for full-size original)
DIFLORASONE DIACETATE
diflorasone diacetate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61748-350
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
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61748-350-15 1 TUBE in 1 CARTON contains a TUBE
1 15 g in 1 TUBE This package is contained within the CARTON (61748-350-15)
2 NDC:61748-350-30 1 TUBE in 1 CARTON contains a TUBE
2 30 g in 1 TUBE This package is contained within the CARTON (61748-350-30)
3 NDC:61748-350-60 1 TUBE in 1 CARTON contains a TUBE
3 60 g in 1 TUBE This package is contained within the CARTON (61748-350-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206572 03/08/2016
Labeler — VersaPharm Incorporated (956741896)
Establishment
Name Address ID/FEI Operations
Ei LLC 105803274 MANUFACTURE (61748-350), PACK (61748-350), ANALYSIS (61748-350)

Revised: 03/2016 VersaPharm Incorporated

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