FDA label ec571f65-5ee6-5de7-e053-2a95a90af041

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
53bdd864-40e7-4d22-e054-00144ff88e88
SPL ID
ec571f65-5ee6-5de7-e053-2a95a90af041
Version
8
Effective date
2022-10-31
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 05:15:59

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

WARNINGS SECTION Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if water fluoridation exceeds 0.7 ppm, since younger patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 requires special supervision to preven repeated swallowing of dental cream which could cause dental fluorosis. Read instructions carefully before using. Keep out of reach of infants and children. OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of infants and children. INSTRUCTIONS FOR USE SECTION Directions: *adults and children 2 years and older: wet a toothbrush and apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician. INACTIVE INGREDIENT SECTION Inactive ingredients; sorbitol, deionized water, hydrated silica, xylitol, glycerin, PEG 400, sodium lauryl sulfate, potassium phosphate monobasic, titanium dioxide, vanilla mint flavor, sodium saccharin OTC - QUESTIONS SECTION Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com OTC - PURPOSE SECTION Helps protect against Cavities and relieve dentinal hypersensitivity DOSAGE & ADMINISTRATION SECTION Directions: adults and pediatric patients 6 and older, apply a thin ribbon of FluoriMax toothpaste to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bed time. After use, adults spit, do not eat, drink or rinse for 30 minutes. Pediatric patients 6-16 spit after use and rinse mouth thoroughly.

Reported adverse events (FAERS/openFDA)#

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