Home FDA labels 57dbfe25-5b60-3ad1-e063-6294a90a0a76 PRO-SYS 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 PRO-SYS
Generic name ORAL WOUND CLEANSER
Manufacturer Forward Science Technologies LLC
Product type HUMAN OTC DRUG
SPL set ID c357c8f8-6fd6-c2f8-e053-2995a90a4023
SPL ID 57dbfe25-5b60-3ad1-e063-6294a90a0a76
Version 7
Effective date 2026-07-30
Source export date 2026-10-27
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run 20261027T193451Z
Imported at 2026-10-27 20:15:46 Harmonized routes table Harmonized routes DENTAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 19 matching rows.
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 Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product, do not swallow. Stop use and ask a dentist or physician if: • sore mouth symptoms do not improve in 7 days; • irritation, pain, or redness persists or worsens; • swelling, rash, or fever develops.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.