FDA label 80b3502e-1bcf-1704-e053-2991aa0aaa5b

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
80b3502e-1bce-1704-e053-2991aa0aaa5b
SPL ID
80b3502e-1bcf-1704-e053-2991aa0aaa5b
Version
1
Effective date
2019-01-30
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 05:12:53

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 & Precautions Do not swallow. Keep this and all drugs out of reach of children. For use only under supervision of a dental professional or physician. Adverse Reactions: Developing teeth of children under 6 years of age may become permanently discolored if excess quantities are repeatedly swallowed. Reactions of individuals whith fluoride hypersensitivity amy include: eczema, atopic dermatitis, uticaria, gastric distress, headache, and weakness. Overdose: If you accidentally swallow more than used for brushing, administer calcium (e.g. milk) and seek professional medical assistance or contact local Poison Control Center immediately. For product SDS information, please see company website at pascaldental.com or contact Pascal directly. Neutragard Gel is free of gluten, milk, soy, egg, peanut and tree nut products. Store product between 59-86ºF (15-30ºC)

Reported adverse events (FAERS/openFDA)#

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