FDA label 93ef3d9e-67e4-33b4-e053-2995a90abed3

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
f38df8ef-b2c9-431e-9062-828b8c77d466
SPL ID
93ef3d9e-67e4-33b4-e053-2995a90abed3
Version
4
Effective date
2019-10-02
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:46:11

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

Warnings: This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful to permanent and may be removed by your dentist.

Reported adverse events (FAERS/openFDA)#

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