FDA label 129c407b-49ed-3152-e054-00144ff8d46c

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
129c407b-49ec-3152-e054-00144ff8d46c
SPL ID
129c407b-49ed-3152-e054-00144ff8d46c
Version
1
Effective date
2015-04-16
Source export date
2026-08-17
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/2026-08-17/28baf16af715ee15453297f68cf3645a4d0fd0920220426fbe9d0c3d228bd86d/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 07:21:02

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 and cautions

Warning: Keep out of reach of children. For topical intraoral use only. For professionally applied, in-office treatment only. Precautions: Not for systemic treatment. Do not swallow. Do not use on patients with an allergy to fluoride. 60 Second Taste contains artificial color and flavor; confirm that no known patient allergies exist (Marshmallow and Chocolate Vanilla are Dye-Free and contain no artificial colors. Special care should be used when administering to children under 6 years of age so that gel is not swallowed. Contact with abraded or sensitive oral tissue may produce discomfort. If moren than is ordinarily used for treatment is swallowed, administer calcium (milk) and contact your local Poison Control Center immediately.