FDA label 38489ae4-7173-b111-e063-6394a90a8f8f

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
3838af9a-92a8-b73a-e063-6294a90a499c
SPL ID
38489ae4-7173-b111-e063-6394a90a8f8f
Version
2
Effective date
2025-06-23
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:38:05

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 ■ Fluorine content of this product is 977ppm. ■ In the following cases, immediately stop using this product and consult a doctor or dentist. (1) If you experience any abnormalities such as injury to your gums or the inside of your mouth while using this product. (2) If a child under 6 years old swallows a large amount. ■ Other precautions when using this product. (1) Be careful not to swallow it and rinse your mouth thoroughly after use. (2) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. ■ Precautions for storage. (1) Keep out of the reach of children under 6 years of age.

Reported adverse events (FAERS/openFDA)#

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