Desoximetasone
Generic: DESOXIMETASONE
Basic Information
Manufacturer
The J. Molner Company LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
2bbb5200-8355-ba86-e063-6394a90a23b6
Indications & Usage
INDICATIONS AND USAGE Desoximetasone Ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Warnings
WARNINGS Keep out of reach of children.
Adverse Reactions
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 (0.2%) for Desoximetasone Ointment USP, 0.05% and included mild burning sensation at the site of application.
To report SUSPECTED ADVERSE REACTIONS , contact The J.
Molner Company LLC at 1-800-552-8750 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 (0.2%) for Desoximetasone Ointment USP, 0.05% and included mild burning sensation at the site of application.
To report SUSPECTED ADVERSE REACTIONS , contact The J.
Molner Company LLC at 1-800-552-8750 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.