FDA label 9b557bc7-f6ef-4e34-831e-927be2e44163

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
433f7e8f-435b-4f10-b25d-1291d90afabd
SPL ID
9b557bc7-f6ef-4e34-831e-927be2e44163
Version
1
Effective date
2022-05-25
Source export date
2026-10-12
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/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:03:44

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 ■ Contains 977ppm of fluoride. ■ Do not swallow and rinse mouth thoroughly after use ■ If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor. ■ 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. ■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. ■ 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.