Amethocaine
Sold as Minims tetracaine, Covostet, Amethocaine, Anethaine, Dynexan, Arcaine
2-(Dimethylamino)ethyl 4-(butylamino)benzoate
Drag to rotate. Structure from PubChem CID 5411.
Background
Registration
- Applicants
- 4
- Registrations
- 6
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Soflens (Pty) Ltd | Minims tetracaine | 1% | C0047 | Not determined | None |
| Adcock ingram limited1 of 3 cancelled | Covostet, Amethocaine, Arcaine | cream | F0010, G1542, H1229 | Not determined | None |
| Zentiva South Africa (Pty) LtdCancelled | Anethaine | Not stated | G1835 | Not determined | None |
| The Premier Pharmaceutical Co Ltd | Dynexan | ointment | G2266 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Minims tetracaine 1% EACH 100 ml CONTAINS AMETHOCAINE HYDROCHLORIDE 1,0 g | 1% | C0047C/15.4/47 | Registered | Not determined | None |
| Covostet EACH 100 ml CONTAINS AMETHOCAINE HYDROCHLORIDE 0,5 g | Not listed | F0010F/15.4/10 | Registered | Not determined | None |
| Amethocaine cream EACH 1 g CONTAINS AMETHOCAINE HYDROCHLORIDE A 0,01 g | Cream | G1542 | Old Medicine | Not determined | None |
| Anethaine EACH 100g CONTAINS AMETHOCAINE HYDROCHLORIDE A 1 g | Not listed | G1835 | Cancelled | Not determined | None |
| Dynexan ointment EACH 100 G OINTMENT CONTAINS: AMETHOCAINE HYDROCHLORIDE A 0,5 G | Ointment | G2266 | Old Medicine | Not determined | None |
| Arcaine EACH 10 ml CONTAINS AMETHOCAINE HYDROCHLORIDE A 0,025 g | Not listed | H1229 | Cancelled | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Tetracaine
- when intended for ophthalmic or parenteral use;
- except when intended for topical use; (S1)
- except in oral preparations containing 2 percent or less of Tetracaine; (S1)
- except when contained in eye drops intended for the emergency treatment of “arc eyes”. (S2)
Consolidated Schedules 06 July 2026, lines 8152 to 8160
S2: Tetracaine
- when contained in eye drops intended for the emergency treatment of “arc eyes”
- except when intended for topical use; (S1)
- except in oral preparations containing 2 percent or less of tetracaine, per dosage unit; (S1)
- except when intended for ophthalmic or parenteral use. (S4)
Consolidated Schedules 06 July 2026, lines 2707 to 2715
S1: Tetracaine
- when intended for topical use;
- in oral preparations containing 2 percent or less of tetracaine, per dosage unit;
- except when contained in eye drops intended for the emergency treatment of “arc eyes”; (S2)
- except when intended for ophthalmic or parenteral use. (S4)
Consolidated Schedules 06 July 2026, lines 1096 to 1104
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
SAHPRA has not published a professional information or patient information leaflet for this product.