FLUORIMAX 5000 SENSITIVE- 1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice 
Elevate Oral Care

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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FluoriMax 5000 1.1% Sodium Fluoride & 5% Potassium Nitrate Toothapste

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 Label

FLUORIMAX 5000 SENSITIVE 
1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN (UNII: FST467XS7D)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorwhiteScore    
ShapeROUNDSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0102-396 g in 1 TUBE; Type 0: Not a Combination Product08/01/201710/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/201710/31/2024
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIBusiness Operations
Elevate Oral Care002863526manufacture(57511-0102)

Revised: 10/2022
Document Id: ec571f65-5ee6-5de7-e053-2a95a90af041
Set id: 53bdd864-40e7-4d22-e054-00144ff88e88
Version: 8
Effective Time: 20221031
 
Elevate Oral Care