Desoximetasone Gel
Name: Desoximetasone Gel
Indications and Usage for Desoximetasone Gel
Desoximetasone Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Contraindications
Desoximetasone Gel USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Warnings
Keep this and all medications out of the reach of children.
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 listed 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.
In controlled clinical studies the incidence of adverse reactions was low (0.3%) for Desoximetasone Gel USP, 0.05% with one subject reporting stinging and burning at the site of application.
How is Desoximetasone Gel Supplied
Desoximetasone Gel USP, 0.05% is supplied in:
15 g tubes (NDC 65179-501-15)
60 g tubes (NDC 65179-501-60)
Store at controlled room temperature between 20º to 25ºC (68º to 77ºF), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]
Manufactured By:
Groupe Parima Inc.
4450 Cousens Montreal
Quebec, Canada H4S 1X6
Made in Canada
Revised: 09/2014
DESOXIMETASONE Desoximetasone Gel | |||||||||||||||||||
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Labeler - GROUPE PARIMA INC (252437850) |
Registrant - GROUPE PARIMA INC (252437850) |
Establishment | |||
Name | Address | ID/FEI | Operations |
GROUPE PARIMA INC | 252437850 | manufacture(65179-501) |