FDA.reportPublic FDA data

FluoriMax 5000 Sensitive

Manufacturer
Elevate Oral Care
Effective date
2022-10-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:50:09

Label at a glance#

ProductFluoriMax 5000 Sensitive
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 1.1% Anticavity

Potassium Nitrate 5% Antisensitivity

INDICATIONS & USAGE SECTION

A dental caries preventive and sensitive teeth toothpaste for once daily self appied topical use. It is well established that 1.1% sodium fluoride is safe and effective as a caries preventive when applied frequently with mouthpiece applicators. Use once daily in place of your regular toothpaste unless otherwise instructed by your dental professional.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FM5Sens LabelFM5Sens Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-010257511-0102-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SACCHARINFST467XS7DIACT
POTASSIUM PHOSPHATE, MONOBASIC4J9FJ0HL51IACT
XYLITOLVCQ006KQ1EIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ec571f65-5ee6-5de7-e053-2a95a90af04153bdd864-40e7-4d22-e054-00144ff88e882022-10-31WarningsExact identifier
spl id: ec571f65-5ee6-5de7-e053-2a95a90af041
spl set id: 53bdd864-40e7-4d22-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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