Fluocinolone Acetonide is a corticosteroid sold in the U.S. under 7 brand and generic names, for atopic dermatitis, facial dermatoses and foot dermatoses. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Capex (application NDA020001). Other fluocinolone acetonide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. ( 2 ) Adult patients: Apply to affected areas 3 times daily. ( 2.1 ) Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.2 ) 2.1 Adult Patients with Atopic Dermatitis Apply Fluocinolone Acetonide Topical Oil, 0.01% as a thin film to the affected areas three times daily . 2.2 Pediatric Patients with Atopic Dermatitis Moisten skin and apply Fluocinolone Acetonide Topical Oil, 0.01% as a thin film to the affected areas twice daily for up to four weeks .
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects An open-label study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of fluocinolone acetonide topical oil, 0.01% when applied to the face twice daily for 4 weeks. The following adverse reactions were reported: Incidence of Adverse Events (%) N=58 Adverse Reaction (AR)* # of subjects (%) Day 14 Day 28** Day 56*** Any AE 15 (26) 6 (10) 7 (12) 7 (12) Telangiectasia 5 (9) 3 (5) 4 (7) 2 (4) Erythema 3 (5) 3 (5) Itching 3 (5) 3 (5) Irritation 3 (5) 3 (5) Burning 3 (5) 3 (5) Hypopigmentation 2 (4) 2 (4) Shiny skin 1 (2) 1 (2) Secondary atopic dermatitis 1 (2) 1 (2) Papules and pustules 1 (2) 1 (2) Keratosis pilaris 1 (2) 1 (2) Folliculitis 1 (2) 1 (2) Facial herpes simplex 1 (2) 1 (2) Acneiform…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Topical | — | — | View → | |
| 2 | Not yet rated | Prescription | Oil | — | — | View → | |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Fluocinolone Acetonide Solution Topical Solution USP
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
SUN PHARMACEUTICAL INDUSTRIES INC · Dec 30, 2025
Fluocinolone Acetonide Oil
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Glenmark Pharmaceuticals Inc., USA · Jan 4, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None None ( 4 ).
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| Topical |
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| 4 | Not yet rated | Prescription | Implant | — | — | View → |
| 5 | Not yet rated | Prescription | Implant | — | — | View → |
| 6 | Not yet rated | Prescription | Topical | — | — | View → |
| 7 | Not yet rated | Prescription | Topical | — | — | View → |