ApexiCon^® E Cream
(diflorasone diacetate cream USP 0.05% [emollient])

Rx only

NOT FOR OPHTHALMIC USE

Each gram of ApexiCon^® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) contains 0.5 mg diflorasone diacetate in a cream base for topical dermatological use.

Chemically, diflorasone diacetate is: 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-diacetate.

The structural formula is represented below:

Each gram of ApexiCon^® E Cream (diflorasone diacetate cream USP 0.05% [emollient]) contains: 0.5 mg diflorasone diacetate in a hydrophilic vanishing cream base of propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, mineral oil and purified water.

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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 uled in an approximate decreasing order of occurrence: 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.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS).

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.

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 Altana Inc.
Duluth, GA 30096 USA
www.pharmaderm.com

I8395B/IF8395B R7/05
#35
R7/05