FDA label a8085ef0-28a1-4643-94f6-1afdd8701f6f

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
f6af454c-e43a-4f3a-a6f2-c58a2f0fdb4e
SPL ID
a8085ef0-28a1-4643-94f6-1afdd8701f6f
Version
4
Effective date
2016-07-14
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:59

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 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.