FDA label f3ac966f-c614-3898-e053-2995a90a49c4

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
f3ac966f-c613-3898-e053-2995a90a49c4
SPL ID
f3ac966f-c614-3898-e053-2995a90a49c4
Version
1
Effective date
2023-01-05
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:32:34

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

1. Products containing peroxides are not recommended for children under the age of 18 and pregnant or lactating women. 2. Regular dental checkups and cleanings are important before and after bleaching to maintain a healthy smile. 3. Do not use this product if you are allergic to any of the ingredients. 4. If you have any questions regarding the appropriate use of this product, including how long it will take to bleach your teeth, please consult a dentist as soon as possible. 5. If irritation occurs such as redness, soreness, or swelling of the gums or mouth, discontinue use and consult a dental professional or physician. 6. Do not swallow. If a significant amount is swallowed, please call Poison Control immediately. 7. Do not use tobacco, and other products can restain your teeth over time. Should this occur, the teeth can be rewhitened within a few nights using gel. 8. Crowns, bridges, partial dentures, veneers, and composite fillings will not bleach. 9. Keep gel out of reach of small children. 10. Store bleach out of the sun and heat. Refrigeration recommended. Do not freeze.

Reported adverse events (FAERS/openFDA)#

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