FDA label 1287d2cd-9109-10cf-e054-00144ff88e88

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
1287d2cd-9108-10cf-e054-00144ff88e88
SPL ID
1287d2cd-9109-10cf-e054-00144ff88e88
Version
1
Effective date
2015-03-30
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:30

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

Warnings and Precautions Keep out of reach of children. For topical intraoral use only. For professionally applied in office fluoride treatment only. Not for systemic treatement. Do no swallow. Do not use on patients with an allergy to fluoride. 60 Second Taste contains artifical 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 abraided or sensitive oral tissue may produce discomfort. If more than is ordinarily used for treatment is swallowed, administer calcium such as milk and contact your local Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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