FDA.reportPublic FDA data

FDA label 1dd6b65e-11df-4ec2-93af-70888a53b1b1

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)

SPL set ID
3830dc3a-98f7-4b56-b3ae-281bb24e2e1f
SPL ID
1dd6b65e-11df-4ec2-93af-70888a53b1b1
Version
1
Effective date
2013-09-17
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:44

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 IF YOU HAVE PAINFUL OR SWOLLEN GUM LINE, LOOSE TEETH OR INCREASED SPACING BETWEEN THE TEETH. SEE YOUR DENTIST IMMEDIATELY. THESE MAY BE SIGNS OF PERIODONTITIS, A SERIOUS FORM OF GUM DISEASE. DO NOT USE FOR CHILDREN UNDER 12 YEARS OF AGE. STOP USE AND ASK A DENTIST IF GINGIVITIS, BLEEDING OR REDNESS PERSISTS FOR MORE THAN 72 HOURS. KEEP OUT OF REACH OF CHILDREN IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.