Adapalene, benzoyl peroxide
Sold as Epiduo, Epiduo forte, Deriva co, Adapalene/benzoyl peroxide glenmark
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 2
- Registrations
- 4
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Galderma Laboratories S.A. (Pty) LtdCertificate held by Galderma Laboratories South Africa (Pty) Ltd | Epiduo, Epiduo forte | 0.1 % / 2.5 %, 3 mg/g, 25 mg/g | 440109, 509031 | Not determined | PIPIL |
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Deriva co, Adapalene/benzoyl peroxide glenmark | 0,1%/2,5% | 510911, 510912.911 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Epiduo 0,1 %/2,5 % EACH 1,0 g GEL CONTAINS ADAPALENE 1,0 mg BENZOYL PEROXIDE 25,0 mg | 0.1 % / 2.5 %Gel | 44010944/13.12/0109Approved 19 November 2021 | Registered | Not determined | PIPIL |
| Epiduo forte Each 1,0 gram contains ADAPALENE 3,0 mg and BENZOYL PEROXIDE 25,0 mg | 3 mg/g, 25 mg/gGel | 50903150/13.12/9031Approved 13 September 2022 | Registered | Not determined | PIPIL |
| Deriva co Each 1,0 gram of gel contains ADAPALENE 1,0 mg and BENZOYL PEROXIDE 25,0 mg | Not listed | 51091151/13.12/0911 | Registered | Not determined | None |
| Adapalene/benzoyl peroxide 0,1%/2,5% gel glenmark Each 1,0 gram of gel contains ADAPALENE 1,0 mg and BENZOYL PEROXIDE 25,0 mg | 0,1%/2,5%Gel | 510912.91151/13.12/0912.911 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.