FDA label d0a6d756-d2cc-4b70-a598-ab48358749bf

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
f4e6b402-84ae-4e46-8258-5c7e5bdd362f
SPL ID
d0a6d756-d2cc-4b70-a598-ab48358749bf
Version
4
Effective date
2016-07-14
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:30

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children under 6 years of age Sodium monofluorophosphate 0.75% (0.13% w/v Fluoride ion) Sodium carboxymethylcellulose, Sodium lauryl sulfate, Sodium saccharin, Sorbitol, Titanium dioxide, Tocopheryl acetate, Water, Hydrated Silica, Menthol, PEG-4, PEG-32, Flavor, Glycerin, Mica, Sage leaf extract, Agar, Alginic acid, Benzethonium chloride, Chamomille flower extract, FD&C Blue No 1 Purpose Anticavity Adults and children 2 years of age and older Brush teeth thoroughly, preferably after each meal or at least twice a day or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing ad rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age Consult a dentist or doctor Aids in the prevention of dental cavities

Reported adverse events (FAERS/openFDA)#

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