FDA.reportPublic FDA data

FDA label b19bd4a1-bfae-67fe-e053-2a95a90a3980

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
319704ba-5c42-4858-e054-00144ff88e88
SPL ID
b19bd4a1-bfae-67fe-e053-2a95a90a3980
Version
5
Effective date
2020-10-14
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:42:49

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 Persons who CANNOT use Lutooth whitening kit. To be on the safe side, pregnant and breastfeeding women, children under the age of 14 should postpone tooth whitening. DO NOT use if teeth or gum are not healthy. Avoid ingestion and contact with eyes and skin. If contact occurs, wipe gel off and rinse with water. The LED device should not be used for other purpose. If sensitivity or gum irritation occurs, please stop using whitening gel and consult your dentist.

Reported adverse events (FAERS/openFDA)#

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