Fluocinolone acetonide
Sold as Synalar scalp oil, Synalar, Synalar n, Cortoderm, Fluoderm
(1S,2S,4R,8S,9S,11S,12R,13S,19S)-12,19-Difluoro-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-16-one
Drag to rotate. Structure from PubChem CID 6215.
Background
Registration
- Applicants
- 2
- Registrations
- 9
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Synalar scalp oil, Synalar, Synalar n | 0,11 mg, gel, cream, ointment | 550064, B0133, G1396, G1397, G1400 | S4 | PIPIL |
| Pharmacare limited û woodmead2 of 4 cancelled | Cortoderm, Fluoderm | ointment, cream | L0029, L0042, L0367, M0058 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Synalar scalp oil EACH 1,0 g OIL CONTAINS FLUOCINOLONE ACETONIDE 0, 11 mg | 0,11 mgTopical scalp oil | 55006455/13.4.1/0064Approved 19 September 2023 | Registered | S4 | PIPIL |
| Synalar gel EACH 1g CONTAINS FLUOCINOLONE ACETONIDE 0,025 g | Gel | B0133B/13.4.1/133 | Registered | Not determined | None |
| Synalar cream EACH 1,0 g CREAM CONTAINS FLUOCINOLONE ACETONIDE A 0,2500 mg | Cream | G1396 | Old Medicine | Not determined | None |
| Synalar ointment EACH 1,0 g OINTMENT CONTAINS FLUOCINOLONE ACETONIDE A 0,25 mg | Ointment | G1397 | Old Medicine | Not determined | None |
| Synalar n EACH 1,0 g CREAM CONTAINS FLUOCINOLONE ACETONIDE A 0,25 mg NEOMYCIN SULPHATE A 3500 i.u | Not listed | G1400 | Old Medicine | Not determined | None |
| Cortoderm ointment EACH 5 G OINTMENT CONTAINS FLUOCINOLONE ACETONIDE 1,25 MG | Ointment | L0029L/13.4.1/29 | Registered | Not determined | None |
| Cortoderm cream EACH 5 G CREAM CONTAINS FLUOCINOLONE ACETONIDE 1,25 MG | Cream | L0042L/13.4.1/42 | Registered | Not determined | None |
| Fluoderm ointment EACH 5 G OINTMENT CONTAINS FLUOCINOLONE ACETONIDE 1,25 MG | Ointment | L0367L/13.4.1/367 | Cancelled | Not determined | None |
| Fluoderm cream EACH 5 g CREAM CONTAINS FLUOCINOLONE ACETONIDE 1,25 mg | Cream | M0058M/13.4.1/58 | Cancelled | Not determined | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S4, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
Schedule Verification
Synalar scalp oil, Glenmark Pharmaceuticals South Africa (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.