Fluocinolone Acetonide

What it is and how it works

Mechanism of Action 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 A 2 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 A 2 .

Mechanism class: Corticosteroid Hormone Receptor Agonists

Indications

Fluocinolone Acetonide Topical Oil, 0.01% is a corticosteroid indicated for the • topical treatment of atopic dermatitis in adult patients • topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks Limitations of Use: • Apply the least amount to cover affected areas. Discontinue when disease is controlled. • Do not use in the diaper area. • Do not use on the face, axillae, or groin. ( 1.3 , 6.2 , 8.4 ) Adult Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. Pediatric Patients with Atopic Dermatitis Fluocinolone Acetonide Topical Oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established. Limitations of Use Apply the least amount of Fluocinolone Acetonide Topical Oil, 0.01% needed to cover the affected areas.

Dosage and administration (summary)

Fluocinolone Acetonide Topical Oil, 0.01% is not for oral, ophthalmic, or intravaginal use. The dosing of Fluocinolone Acetonide Topical Oil, 0.01% is different for adult and pediatric patients. Fluocinolone Acetonide Topical Oil, 0.01% is not for oral, ophthalmic, or intravaginal use. • Adult patients: Apply to affected areas 3 times daily. • Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. Adult Patients with Atopic Dermatitis Apply Fluocinolone Acetonide Topical Oil, 0.01% as a thin film to the affected areas three times daily .

Contraindications

None None .

Warnings and precautions

• Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. • Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. • Modify use should HPA axis suppression develop. • Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption.

Pregnancy

Pregnancy 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.

Storage and supply

Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) NDC: 72162-1434-2: 118.28 mL in a BOTTLE Storage: Store at 25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) . Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Source: Fluocinolone Acetonide (Fluocinolone Acetonide) — US FDA prescribing information, 2026-05-26, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.