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DESONIDE OINTMENT, 0.05%
Rx only
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Desonide Ointment, 0.05% contains microdispersed desonide (the active ingredient) in white petrolatum. Each gram of desonide ointment contains 0.5 milligrams of desonide. Desonide Ointment is applied topically.
Desonide is a non-fluorinated corticosteroid. Chemically, desonide is pregna-1,4-diene-3,20-dione,11, 21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11 β,16 α)-with the following structural formula:
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic 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.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
PRECAUTIONS
ADVERSE REACTIONS
The following local adverse reactions are reported infrequently 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, Miliaria.
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
DOSAGE AND ADMINISTRATION
Topical corticosteroids are generally applied to the affected area as a thin film from two to three times daily depending on the severity 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 instituted.
HOW SUPPLIED
Desonide Ointment, 0.05% is supplied in 15 and 60 gram tubes. It is white or faintly yellowish, transparent semisolid.
15 gram tubes, NDC 0168-0309-15
60 gram tubes, NDC 0168-0309-60
Store below 30°C (86°F). Avoid freezing.
E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747
www.fougera.com
I2309
R7/00
#284