Fluocinolone Acetonide
.11 mg/118.28mL · Oil
- Prescription only
- Corticosteroid
- Active substance
- Fluocinolone Acetonide
- Made by
- Amneal Pharmaceuticals LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
This information is not included in the verified source. Open the official leaflet
How it works
From the US prescribing label for the same active substance (DERMA-SMOOTHE/FS). It describes the substance, not this exact product.
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in psoriasis of the scalp is unknown.
Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-09
Safety of the active substance
From the US prescribing label for the same active substance (DERMA-SMOOTHE/FS). It describes the substance, not this exact product.
The most common adverse reactions in pediatric subjects treated for atopic dermatitis (≥5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Amneal Pharmaceuticals LLC |
|---|---|
| Active substance | Fluocinolone Acetonide |
| Used in | Hormones, such as thyroid and steroids |
| Strength | .11 mg/118.28mL |
| Form | Oil |
| Route | Topical |
| Packs | 1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE |
| NDC | 65162-703 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
19 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Oil9 products
.01 mg/100mL3
.01 mg/100mL · 3 companies
.11 mg/118.28mL2
.11 mg/118.28mL · 2 companies
- Amneal Pharmaceuticals LLC · this page
- Sun Pharmaceutical Industries, Inc.
.11 mg/mL4
- Cream4 products
.1 mg/g2
.1 mg/g · 2 companies
.25 mg/g2
.25 mg/g · 2 companies
- Solution3 products
.1 mg/mL3
- Ointment3 products
.25 mg/g3
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.