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Betadine Antiseptic

Povidone-iodine

S0Read from the PI-PIL document and verified

No structure available

This product's active ingredient could not be matched to a single known compound.

Registration

Applicants
2
Registrations
4
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Inova Pharmaceuticals (Pty) LtdCertificate held by Mundipharma (Pty) LtdBetadine antisepticsolution, 100 mg / 1 g560372, 570506S0PIPIL
Mundipharma (Pty) LtdCancelledBetadine antisepticsolution, 100 mg / 1 gG1570, G1574S0PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Betadine antiseptic solution

EACH 1,0 ml SOLUTION CONTAINS POVIDONE-IODINE 100,0 mg

Solution56037256/13.1/0372RegisteredNot determinedNone
Betadine antiseptic ointment

EACH 1,0 g OF OINTMENT CONTAINS: POVIDONE-IODINE 100,0 mg

100 mg / 1 gOintment57050657/13.1/0506Approved 2 September 2025RegisteredS0PIPIL
Betadine antiseptic solution

EACH 10,0 ml SOLUTION CONTAINS POVIDONE-IODINE A 1,0 g

SolutionG1570CancelledNot determinedNone
Betadine antiseptic ointment

EACH 1,0 g OINTMENT CONTAINS POVIDONE-IODINE A 100,0 mg EQUIVALENT TO IODINE 10,0 mg

100 mg / 1 gOintmentG1574Approved 2 September 2025CancelledS0PIPIL

Regulatory status

Where S0 sits on the scale

Sold anywhere, no pharmacist needed.

This is the least restricted tier of medicine. You can buy it in an ordinary shop such as a supermarket or petrol station, and no pharmacist needs to be involved in the sale. It may also be advertised to the public, subject to the general advertising rules that apply to all medicines; the label must still carry the schedule mark like every other tier.

Schedule S0, read from the product's PI-PIL leaflet.

The Consolidated Schedules list this ingredient up to S2; the leaflet's S0 applies to this product.

Who may supply: Anyone. It may be sold in an ordinary shop, not only in a pharmacy.

Consolidated Schedules listings for Povidone-iodine

  • S2: Povidone iodine

    • when intended for application to the vagina.

    Consolidated Schedules 06 July 2026, line 2571

Pharmacological class: Antiseptics, disinfectants and cleansing agents. (class 13.1)

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.

Background

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SAHPRA documents

Schedule verified from official documents

Schedule Verification

Betadine antiseptic ointment, Inova Pharmaceuticals (Pty) Ltd is scheduled S0 in its official SAHPRA documents, read with 90% confidence.

These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.

Research articles

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