FDA.reportPublic FDA data

Proctosan Cream

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Proctosan Cream
Generic name
RATANHIA, AESCULUS HIPPOCASTANUM, COLLINSONIA CANADENSIS, PAEONIA OFFICINALIS, NEGUNDO
Manufacturer
Seroyal USA
Product type
HUMAN OTC DRUG
SPL set ID
271fa97c-2aa7-5607-e054-00144ff88e88
SPL ID
c71ee0b8-3c79-07b1-e053-2995a90a28de
Version
5
Effective date
2021-07-14
Source export date
2026-08-08
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/13477f292fde418ab8b889dedaeed5fd633628cccdf0fe6d78a20f4b857aa1ee/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 17:34:13
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external and intrarectal use only. Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly. When using this product do not exceed the recommended daily dosage unless directed by a doctor. Stop use and ask a doctor In case of bleeding. If condition worsens or does not improve within 7 days. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.