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Flac Otic Oil

Generic: fluocinolone acetonide

Verified·Apr 23, 2026
Manufacturer
CMP Pharma, Inc.
NDC
39328-079
RxCUI
1191299
Route
AURICULAR (OTIC)
ICD-10 indication
H60.50

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About Flac Otic Oil

What is this medication? Flac Otic Oil is a prescription corticosteroid medication primarily used to treat chronic eczematous external otitis, which is a long-term inflammatory condition affecting the outer ear canal. The active ingredient, fluocinolone acetonide, works by reducing the production of chemicals in the body that cause inflammation. This helps to relieve common symptoms associated with ear eczema, such as persistent itching, redness, and swelling of the skin inside the ear canal. This medication is specifically designed for topical application in the ear and is often prescribed when milder treatments have not provided sufficient relief. Because it is an oil-based solution, it helps to soothe and protect the sensitive skin of the ear canal while delivering the medication. It should only be used as directed by a healthcare professional, and it is important to ensure the eardrum is intact before starting treatment to avoid potential complications or damage to the inner ear.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for Flac Otic Oil. Official source: DailyMed (NLM) · Label effective Nov 19, 2024

Indications and 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 and administration
DOSAGE AND 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.
Contraindications
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
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%.
Use in pregnancy
Pregnancy Teratogenic effects Pregnancy category C Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide oil, 0.01%. Therefore, fluocinolone acetonide oil, 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How Flac Otic Oil appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

67%

3,678 of 5,509 plans

Most common tier

Tier 4

On 46% of covering formularies

Prior authorization required

0%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)30
17%
Tier 2 (generic)25
14%
Tier 3 (preferred brand)39
23%
Tier 4 (non-preferred brand)79
46%

Step therapy: 0% of formularies

Quantity limits: 0% of formularies

Coverage breadth: 173 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Related drugs

How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.