FDA.reportPublic FDA data

FDA label 11ec93e3-50f3-4e4b-8e82-b85b97040660

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
fc60bcf4-f7b7-4b68-9e54-f66590d53a80
SPL ID
11ec93e3-50f3-4e4b-8e82-b85b97040660
Version
1
Effective date
2020-07-07
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:05:10

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 The toothpaste contains 452ppm of fluorine. Do not swallow. Rinse mouth after use. Stop use and consult a dentist or a doctor if anomalies occur in the mouth or on the gums after use. For children under 6 years use a pea-sized amount per use and supervise brushing to minimize swallowing. If more than used for brushing is swallowed by children under 6 years, consult a doctor or a dentist immediately. Keep out of reach of children under 6 years of age.

Reported adverse events (FAERS/openFDA)#

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