FDA label 05fb5be5-547a-4558-8bf4-cf9d7efb007e

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
6b6e6a38-2e62-47cb-a54e-a25c4feb2051
SPL ID
05fb5be5-547a-4558-8bf4-cf9d7efb007e
Version
1
Effective date
2014-02-08
Source export date
2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:20:52

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

*Be careful if you are with these troubles below. -Allergic to hydrogen peroxide -Infection in the mouth, damages on your teeth, gum diseases -Teeth Calibration in progress *Specific Caution : -If you have a toothache, reduce the usage to once a day. If your toothache lasts longer, stop using it for 2~3 days and start using it again. -If gum diseases or intraoral troubles, stop using it. -If you have a toothache continuously, then go to see a dentist. -Use the appropriate amount of the product. -Do not swallow. -In case of accidental ingestion, seek professional assistance. -When pregnant or lactating women use the product, check with a doctor before using it. -In case of the usage by kids under 12 years of age, seek for professional assistance first. -While the gel is applied onto your teeth, do not eat, drink, smoke, or wash your face. - Be careful not to make clothes to be stained with the gel.

Reported adverse events (FAERS/openFDA)#

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