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Clotrimazole (Canesten Duopak, Canesten 3vc, Canesten Vaginal, Canesten Topical, Canesten Vc)

Clotrimazole

Bayer (Pty) Ltd û Isando

S1Read from the PI-PIL document and verified

Registration

Applicant
Bayer (Pty) Ltd û Isando
Certificate holder
Bayer
Registrations
7
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Canesten duopak

Referred to CLOTRIMAZOLE A

500mg, 100mg / 10gVaginal tablet & cream30011130/20.2.2/0111Approved 20 March 2018RegisteredNot determinedPIPIL
Canesten 3vc

EACH 1,0 g CREAM CONTAINS CLOTRIMAZOLE 20,0 mg

20mg / 1gVaginal creamA390589A39/20.2.2/0589Approved 26 October 2012RegisteredS1PIPIL
Canesten vaginal tablets

EACH TABLET CONTAINS CLOTRIMAZOLE 100 mg

TabletsE0047E/20.2.2/47CancelledNot determinedNone
Canesten topical cream

EACH 20 g CREAM CONTAINS CLOTRIMAZOLE 200,0 mg

CreamE0049E/20.2.2/49RegisteredNot determinedNone
Canesten vaginal cream

EACH 5 g CONTAINS CLOTRIMAZOLE 50 mg

CreamK0187K/20.2.2/187CancelledNot determinedNone
Canesten 1 vaginal tablet

EACH VAGINAL TABLET CONTAINS CLOTRIMAZOLE 50,0 mg

1TabletQ0281Q/20.2.2/281RegisteredNot determinedNone
Canesten 1 vc

EACH 5 g VAGINAL CREAM CONTAINS CLOTRIMAZOLE 0,5 g

500mg / 5gVaginal creamU0205U/20.2.2/205Approved 12 December 2017RegisteredNot determinedPIPIL

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.

C22H17ClN2344.80 g/mol

1-[(2-Chlorophenyl)-diphenylmethyl]imidazole

Drag to rotate. Structure from PubChem CID 2812.

SAHPRA documents

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Background

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Research articles

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