FDA.reportPublic FDA data

FDA label 97521927-60ac-6b20-e053-2a95a90ae353

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
91b607d3-43e9-4256-8ec0-42c2fd25106a
SPL ID
97521927-60ac-6b20-e053-2a95a90ae353
Version
6
Effective date
2019-11-14
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:36

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warning Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Ask a dentist before use if you have bleeding or redness lasting more than 2 weeks pain, swelling, pus, loose teeth, or more spacing between teeth These may be signs of peridontitis , a serious form of gum disease.

warnings

Ask a dentist before use if you have bleeding or redness lasting more than 2 weeks pain, swelling, pus, loose teeth, or more spacing between teeth These may be signs of peridontitis , a serious form of gum disease.

Reported adverse events (FAERS/openFDA)#

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