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Miconazole (Gyno-daktarin, Daktarin)

Miconazole

Johnson & Johnson (Pty) Ltd û East London

S1Read from the PI-PIL document and verified

Registration

Applicant
Johnson & Johnson (Pty) Ltd û East London
Registrations
2
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Gyno-daktarin 1 200 MG

EACH OVULE CONTAINS MICONAZOLE NITRATE 1 200,0 mg

200 mg 129034929/18.6/0349CancelledNot determinedNone
Daktarin 2%

EACH g CONTAINS MICONAZOLE 20 mg

20mg / 1gCreamL0183L/20.2.2/183Approved 25 November 2011RegisteredS1PIPIL

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 Miconazole

  • 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: 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

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.

C18H14Cl4N2O416.10 g/mol

1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole

Drag to rotate. Structure from PubChem CID 4189.

SAHPRA documents

Schedule verified from official 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.

Background

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Research articles

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