FDA.reportPublic FDA data

FDA label 7f10d5a6-2d5c-7ce2-e053-2991aa0ab425

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
7f10d5a6-2d5b-7ce2-e053-2991aa0ab425
SPL ID
7f10d5a6-2d5c-7ce2-e053-2991aa0ab425
Version
1
Effective date
2019-01-09
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 05:13:38

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

● Caution : 1) The fluoride content of this product is 90.5ppm. 2) Do not use this product - Anyone who is hypersensitive to this product. 3) Other Precautions when using this product-Do not swallow. Do not use for children under 6 years old unless instructed by a dentist. Keep out of reach of children. If they drink lots of medicine, feed large amounts of milk and follow doctor's instructions. 4) Storage precautions and other precautions when using this product-Keep out of the reach of children. Avoid direct sunlight. To shade the light, store in a cool place. To prevent misuse and preserve quality, do not change the container.

Reported adverse events (FAERS/openFDA)#

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