FDA label f0392984-11ef-5dc7-e053-2995a90a5630

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
1233853f-01af-6305-e054-00144ff88e88
SPL ID
f0392984-11ef-5dc7-e053-2995a90a5630
Version
3
Effective date
2022-12-19
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:03:02

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

Warnings and Precautions Keep out or reach of children. For topical intraoral use only. For professionally applied, in office fluoride treatment only. Not for system treatment. Do no 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 aritifical 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 in 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.