Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CREAM
**3\. Dosage and Administration** FESPIXON is prescription-only. FESPIXON shall be topically applied to the lesion twice daily by fully covering the ulcer. Once FESPIXON is applied, gauze should be used to cover the ulcer area. The lesion shall avoid being overwrapped until healing of ulcer has occurred.
TOPICAL
Medical Information
**2\. Indication** **Diabetic foot ulcer** Note: The clinical trial results are based on the subjects with non-ischaemic Wagner Grade 1 and Grade 2 chronic diabetic ulcers without active infection.
**4\. Contraindications** FESPIXON is contraindicated in the patients who are hypersensitive to the ingredients of FESPIXON, including _Plectranthus amboinicus_, _Centella asiatica_ or excipients.
Pending
xpending
Manufacturer Information
PHARMENG TECHNOLOGY PTE. LTD.
Oneness Biotech Co., Ltd., Nanchou Plant
Active Ingredients
Plectranthus amboinicus extract (PA-F4)
2.5mg/g
plectranthus amboinicus extract (pa-f 4)
Documents
Package Inserts
Fespixon PI approved 2023.pdf
Approved: January 31, 2023