FDA label 12360727-2599-3365-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
12360727-2598-3365-e054-00144ff88e88
SPL ID
12360727-2599-3365-e054-00144ff88e88
Version
1
Effective date
2015-03-26
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:10

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 not swallow. Do not use on patients with an allergy to fluoride pH7 Gel contains artificial flavor and color; confirm that no known patient allergies exist. 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 more than is ordinarily used for treatment is swallowed, adminster 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.