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Lidocaine, prilocaine

Sold as Emla, Topla

S1Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Background

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Registration

Applicants
2
Registrations
3
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Pharmacare limited û woodmeadCertificate held by Pharmacare limitedEmla5%, 25 mg/ 25 mg300478, Z0051S1PIPIL
Cipla Medpro (Pty) LtdCancelledToplaNot stated330174Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Emla patch

EACH PATCH CONTAINS LIDOCAINE 25,0 mg PRILOCAINE 25,0 mg

25 mg/ 25 mgPatches30047830/4/0478Approved 2 February 2023RegisteredS1PIPIL
Topla

EACH 1,0 g CREAM CONTAINS LIDOCAINE 25,0 mg PRILOCAINE 25,0 mg

Not listed33017433/4/0174CancelledNot determinedNone
Emla 5%

EACH 1,0 g CREAM CONTAINS LIDOCAINE 25,0 mg PRILOCAINE 25,0 mg

5%Z0051Z/4/51RegisteredNot determinedNone

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 Lidocaine, prilocaine

  • S4: Lidocaine

    • when intended for ophthalmic or parenteral use;
    • when intended for the treatment of neuropathic pain associated with previous herpes zoster infection;
    • except when intended for topical use; (S1)
    • except in oral preparations containing 2 percent or less of lidocaine per dosage form. (S1)

    Consolidated Schedules 06 July 2026, lines 6923 to 6935

  • S4: Prilocaine

    • when intended for ophthalmic or parenteral use; (S4)
    • except in topical preparations containing 10 percent or less of prilocaine. (S1)

    Consolidated Schedules 06 July 2026, lines 7638 to 7642

  • S1: Lidocaine

    • when intended for topical use;
    • in oral preparations containing 2 percent or less of lidocaine, per dosage unit;
    • except when intended for ophthalmic or parenteral use; (S4)
    • except when intended for the treatment of neuropathic pain associated with previous herpes zoster infection. (S4)

    Consolidated Schedules 06 July 2026, lines 777 to 786

  • S1: Prilocaine

    • in topical preparations containing 10 percent or less of prilocaine;
    • except when intended for ophthalmic or parenteral use. (S4)

    Consolidated Schedules 06 July 2026, lines 1031 to 1035

Pharmacological class: Local anaesthetics (class 4)

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

Schedule verified from official documents

Schedule Verification

Emla patch, Pharmacare limited û woodmead is scheduled S1 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsEmla patch, Pharmacare limited û woodmeadPatient information leaflet (PIL)For patients and carersEmla patch, Pharmacare limited û woodmead

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

Research articles

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