Clotrimazole (Fungistop Topical, *Fungistop Vaginal, Clofunzo Vaginal, Clofunzo Topical)
Clotrimazole
Biotech Laboratories (Pty) Ltd
Registration
- Applicant
- Biotech Laboratories (Pty) Ltd
- Certificate holder
- Biotech Laboratories (Pty) Ltd
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Fungistop topical EACH 1 g CREAM CONTAINS CLOTRIMAZOLE 10,0 mg | 10 mgCream | 27033727/20.2.2/0337Approved 29 September 2023 | Registered | S1 | PIPIL |
| *Fungistop vaginal EACH 100 g CREAM CONTAINS :CLOTRIMAZOLE 1,0 g | 10 mgCream | 27033827/20.2.2/0338Approved 17 March 2026 | Registered | S1 | PIPIL |
| Clofunzo vaginal EACH 1,0 g CREAM CONTAINS CLOTRIMAZOLE 10,0 mg | 10 mgCream. | 59066059/20.2.2/0660Approved 17 March 2026 | Registered | S1 | PIPIL |
| Clofunzo topical EACH 1,0 g CREAM CONTAINS CLOTRIMAZOLE 10,0 mg | Not listed | 59066159/20.2.2/0661 | Registered | Not determined | None |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S1 applies to this product.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Clotrimazole
S4: Clotrimazole
- except when intended for application to the skin (S1) and when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)
Consolidated Schedules 06 July 2026, lines 5859 to 5860
S1: Clotrimazole
- when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and
- when intended for application to the skin. (S4)
Consolidated Schedules 06 July 2026, lines 330 to 335
Pharmacological class: Fungicides. (class 20.2.2)
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.
1-[(2-Chlorophenyl)-diphenylmethyl]imidazole
Drag to rotate. Structure from PubChem CID 2812.
SAHPRA documents
Schedule Verification
This medication's schedule (S1) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.