Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
OINTMENT
**Dosage and direction for use:** Apply the ointment in small quantity with the finger on the painful pruritic area morning and evening after each stool. For deep application, attach cannula to tube, insert to full extent and squeeze tube gently from lower end whilst withdrawing. The ointment may be used separately or concurrently with the suppositories.
TOPICAL
Medical Information
**Indications:** 1. For the treatment of internal and external hemorrhoids 2. Hemorrhoids in pregnancy and post-partum 3. Anal pruritus, peri-anal eczema, anal fissure and proctitis 4. Post-haemorrhoidectomy application to relieve pain and discomfort
**Contraindications:** Known hypersensitivity to any of the ingredients. In pregnant animals administration of corticosteroids can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids should not be used extensively in pregnancy, ie in large amounts of for long periods. Hydrocortisone may pass into human breast milk. This product should not be used in pregnancy or lactation unless considered essential by the physician. Topical corticosteroid preparations are contraindicated in the presence of untreated infections of viral, bacterial, tuberculous, parasitic or fungal origin.
C05AA01
hydrocortisone
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
Bausch Health Companies Inc.
Active Ingredients
Documents
Package Inserts
1.4.3 Proctosedyl Ointment 15g PI_v01_Aug20_Clean.pdf
Approved: August 25, 2021