Medicine
Dermotic 0.11 mg/mL oil
Dermotic 0.11 mg/mL oil is a prescription medicine containing Fluocinolone acetonide for otic use, marketed by Royal Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F).
Key facts
- Active ingredient (INN)
- Fluocinolone acetonide
- Brand
- Dermotic
- Strength
- 0.11 mg/mL
- Dosage form
- Oil
- Route
- Otic
- Packs
- 1 bottle
- Marketing authorisation holder
- Royal Pharmaceuticals
- Manufacturer
- Royal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C05AA10 Fluocinolone acetonide
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 November 2005
- Identifiers
- RxCUI 1191299, 1191301DailyMed set ID eb00f222-8105-4e05-90e8-bbd129784364NDC 68791-103Application NDA019452
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, dropper in 1 carton / 20 mL in 1 bottle, dropper | 68791-103-20 | Royal Pharmaceuticals | 9 November 2005 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Fluocinolone acetonide 0.11 mg/mL oil.
- Fluocinolone acetonide 0.11 mg/mL oilAvailable on request—US FDA6 packs
- Fluocinolone acetonide 0.11 mg/mL oilAvailable on request—US FDA4 packs
- FLUOCINOLONE ACETONIDE Oil 0.11 mg/mL oilAvailable on requestRising Pharma HoldingsUS FDA2 packs
- Derma-Smoothe/FS 0.11 mg/mL oilAvailable on requestRoyal PharmaceuticalsUS FDA2 packs
- Flac Otic Oil 0.11 mg/mL oilAvailable on requestPatrin PharmaUS FDA1 pack
- Fluocinolone Acetonide Oil 0.11 mg/mL oilAvailable on requestRising Pharma HoldingsUS FDA1 pack
Other strengths and forms of Fluocinolone acetonide
Clinical summary
Fluocinolone acetonide is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It is available as oil, topical solution and cream for otic and intravitreal use. MedsAcross supplies Fluocinolone acetonide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Fluocinolone acetonideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- fluocinolone acetonide prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Dermotic 0.11 mg/mL oil for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.