Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinolone acetonide oil, 0.01% (ear drops) is supplied in a 1 fluid ounce bottle containing 20 mL net content (Dropper Included). (NDC # 70752-159-20). Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.) [see USP Controlled Room Temperature]. Discard fluocinolone acetonide oil, 0.01% (ear drops) 2 months after initial use. CAUTION: Rx only Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52027 Rev. 04/21; PACKAGE LABEL PRINCIPAL DISPLAY PANEL 20 mL Carton NDC 70752- 159 -20 Fluocinolone Acetonide Oil, 0.01% (Ear Drops) For Otic Use Only Not for Ophthalmic Use Rx only 20 mL carton
- HOW SUPPLIED Fluocinolone acetonide oil, 0.01% (ear drops) is supplied in a 1 fluid ounce bottle containing 20 mL net content (Dropper Included). (NDC # 70752-159-20). Keep tightly closed. Store at 20°-25° C (68° to 77° F); excursions permitted to 15°-30° C (59°-86°F.) [see USP Controlled Room Temperature]. Discard fluocinolone acetonide oil, 0.01% (ear drops) 2 months after initial use. CAUTION: Rx only Manufactured for: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52027 Rev. 04/21
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL 20 mL Carton NDC 70752- 159 -20 Fluocinolone Acetonide Oil, 0.01% (Ear Drops) For Otic Use Only Not for Ophthalmic Use Rx only 20 mL carton
Overview
Fluocinolone acetonide oil, 0.01% (ear drops) contain fluocinolone acetonide {(6α, 11β, 16α)-6,9- difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. structure
Indications & Usage
INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.
Dosage & Administration
For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil, 0.01% into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then, gently pull the ear lobe backward and upward and apply 5 drops of fluocinolone acetonide oil, 0.01% into the ear. Keep head tilted for about a minute to allow fluocinolone acetonide oil, 0.01% to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.
Warnings & Precautions
No warnings available yet.
Contraindications
Fluocinolone acetonide oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. This product contains refined peanut oil NF (see PRECAUTIONS ).
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 oil, 0.01%. To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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