ApexiCon E (Page 2 of 2)

Geriatric Use:

Clinical studies of diflorasone diacetate topical formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS

The following 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 ANI Pharmaceuticals, Inc. at 1-800-308-6755 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

ApexiCon® E Cream (diflorasone diacetate cream 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.

For topical use 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

ApexiCon® E Cream (diflorasone diacetate cream USP, 0.05% [emollient]) is available in the following size tubes:
NDC 62559-365-30 30 gram tube
NDC 62559-365-60 60 gram tube

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

Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
logo

46291084A/46291087A
N6800 Rev 09/21
#56

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 62559-365 -30
ApexiCon® E Cream (diflorasone diacetate cream USP 0.05% [emollient])
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
Rx only
30 g

Carton
(click image for full-size original)

APEXICON E
diflorasone diacetate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-365
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
Stearyl Alcohol
Cetyl Alcohol
Sorbitan Monostearate
Mineral Oil
Water
Polysorbate 60
Propylene Glycol
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-365-30 1 TUBE in 1 CARTON contains a TUBE
1 30 g in 1 TUBE This package is contained within the CARTON (62559-365-30)
2 NDC:62559-365-60 1 TUBE in 1 CARTON contains a TUBE
2 60 g in 1 TUBE This package is contained within the CARTON (62559-365-60)
3 NDC:62559-365-26 6 TUBE in 1 CARTON contains a TUBE
3 2 g in 1 TUBE This package is contained within the CARTON (62559-365-26)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076263 10/20/2022
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 10/2022 ANI Pharmaceuticals, Inc.

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