ApexiCon E (Page 2 of 2)

DOSAGE AND ADMINISTRATION

ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) should be applied to the affected areas 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

ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) is available in the following size tubes:

NDC 0462-0395-30 30 gram tube

NDC 0462-0395-60 60 gram tube

Store at controlled room temperature 20° — 25°C (68° -77°F) [see USP].

PharmaDerm®
A division of Nycomed US Inc.
Melville, New York, 11747 USA
www.pharmaderm.com

I8395C/IF8395C
R1/08

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G LABEL

NDC 0462-0395-30

PharmaDerm®

ApexiCon® E Cream

(diflorasone diacetate cream USP 0.05% [emollient])

FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE

Rx only 30 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G LABEL
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON

NDC 0462-0395-30

PharmaDerm®

ApexiCon® E Cream

(diflorasone diacetate cream USP 0.05% [emollient])

FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE

Rx only 30 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G LABEL

NDC 0462-0395-60

PharmaDerm®

ApexiCon® E Cream

(diflorasone diacetate cream USP 0.05% [emollient])

FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE

Rx only 60 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G LABEL
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON

NDC 0462-0395-60

PharmaDerm®

ApexiCon® E Cream

(diflorasone diacetate cream USP 0.05% [emollient])

FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE

Rx only 60 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON
(click image for full-size original)
APEXICON E
diflorasone diacetate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0462-0395
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
diflorasone diacetate (diflorasone diacetate) diflorasone diacetate 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Stearyl Alcohol
Cetyl Alcohol
Sorbitan Monostearate
Mineral Oil
Water
Polysorbate 60
Propylene Glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0462-0395-30 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (0462-0395-30)
2 NDC:0462-0395-60 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (0462-0395-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076263 09/30/2009
Labeler — PharmaDerm, A division of Nycomed US Inc. (043838424)
Registrant — Nycomed US Inc. (043838424)
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 043838424 ANALYSIS
Establishment
Name Address ID/FEI Operations
Nycomed US Inc. 174491316 MANUFACTURE

Revised: 09/2009 PharmaDerm, A division of Nycomed US Inc.

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