Fluocinolone Acetonide Oil
Generic: FLUOCINOLONE ACETONIDE
Basic Information
Manufacturer
A-S Medication Solutions
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
0ff97af2-04d6-478e-8abe-ca5a0c675708
Indications & Usage
INDICATION AND USAGE Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).
Adverse Reactions
ADVERSE REACTIONS The following local adverse reactions have been reported infrequently with topical corticosteroids.
They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids.
These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%.
A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide topical oil, 0.01% when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events).
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.
table
They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids.
These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with fluocinolone acetonide topical oil, 0.01%.
A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of fluocinolone acetonide topical oil, 0.01% when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events).
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.
table