Label: FLUOCINOLONE ACETONIDE OIL oil

NDC 64980-329-20
For Otic Use Only
Not for Ophthalmic Use

Fluocinolone Acetonide Oil 0.01% (Ear Drops) contains 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. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:

Fluocinolone acetonide in fluocinolone acetonide oil 0.01% 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% 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.

Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear.

However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics:  The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.

Fluocinolone acetonide oil 0.01% is in the low to medium range of potency as compared with other topical corticosteroids.

Efficacy in a placebo-controlled study for the treatment of chronic eczematous external otitis on 154 patients (adults and children 2 years of age and older) treated with five drops per ear of fluocinolone acetonide oil 0.01% twice daily, after 7 days of treatment, showed fluocinolone acetonide oil 0.01% to be superior to placebo in clearing the signs and symptoms of eczematous external otitis.

Clinical safety studies were conducted on the same formulation of fluocinolone acetonide oil 0.01%, marketed as fluocinolone acetonide topical oil, 0.01%. Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6μg/dL; normal: cortisol > 7μg/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18 μg/dL).

A clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide topical oil, 0.01% and histamine/saline controls on the 13 individuals. These subjects were also treated with fluocinolone acetonide topical oil, 0.01% twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil, 0.01% use. Importantly, the bulk peanut oil NF, used in fluocinolone acetonide topical oil, 0.01% is heated between 232˚C – 246˚C (450˚F – 475˚F) for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.

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.

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).

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%.

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.

Topically applied fluocinolone acetonide oil 0.01% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

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.

Fluocinolone Acetonide Oil 0.01% (Ear Drops) is supplied in 1 fluid ounce bottles containing 20 mL (Dropper Included) (NDC # 64980-329-20).
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 by:
Lyne Laboratories, Inc., Brockton, MA 02301

Manufactured for:
Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Revised: 04/2025

PIR32920-00

———PRINCIPAL DISPLAY PANEL———
Rising® 
PHARMACEUTICALS

NDC 64980-329-20FluocinoloneAcetonide Oil0.01%(EAR DROPS)

FOR OTIC USE ONLY
NOT FOR OPHTHALMIC USE
Net Contents 20 mL              Rx only