Hydrocortisone, miconazole
Sold as Elozart, Daktacort
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 2
- Registrations
- 2
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Lebasi Pharmaceuticals (Pty) Ltd | Elozart | Not stated | 350392 | Not determined | None |
| Janssen Pharmaceutica (Pty) LtdCancelled | Daktacort | Not stated | M0173 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Elozart EACH 1,0 g CREAM CONTAINS HYDROCORTISONE 10,0 mg MICONAZOLE NITRATE 20,0 mg | Not listed | 35039235/13.4.1/0392 | Registered | Not determined | None |
| Daktacort EACH g CONTAINS HYDROCORTISONE 10 mg MICONAZOLE NITRATE 20 mg | Not listed | M0173M/13.4.1/173 | 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: Hydrocortisone
- maximum concentration of 1 percent in preparations intended for application to the skin, and
- in a maximum concentration of 1 percent used in combination with miconazole for topical application in the treatment of athlete’s foot. (S2)
Consolidated Schedules 06 July 2026, lines 6648 to 6652
S4: Miconazole
- except when intended for application to the skin; (S1) and
- except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis; (S1) and
- except when intended for human use in preparations containing 2 per cent or less of miconazole, when intended for the topical treatment of fungal infections of the mouth (oral candidiasis). (S2)
Consolidated Schedules 06 July 2026, lines 7125 to 7130
S2: Hydrocortisone
- maximum concentration of 1 percent in preparations intended for application to the skin, and
- in a maximum concentration of 1 percent used in combination with miconazole for topical application in the treatment of athlete’s foot. (S4)
Consolidated Schedules 06 July 2026, lines 2110 to 2114
S2: Miconazole
- when intended for human use in preparations containing 2 percent or less of miconazole, for the topical treatment of fungal infections of the mouth (oral candidiasis). (S1, S4)
Consolidated Schedules 06 July 2026, lines 2347 to 2348
S1: Miconazole
- when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and
- when intended for application to the skin. (S4)
- except for topical treatment of fungal infections of the mouth. (S2)
Consolidated Schedules 06 July 2026, lines 838 to 851
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.