FLUORIMAX 5000- 1.1% sodium fluoride 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 Fluorida Toothpaste Vanilla Mint Twin Pack

Warnings

Warnings

Directions
Instructions For Use

Directions

Package Label and Instructions for use

Primary Package Label

FLUORIMAX 5000 
1.1% sodium fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57511-0504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
SACCHARIN (UNII: FST467XS7D)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScore    
ShapeROUNDSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0504-22 in 1 BOX06/15/2022
1NDC:57511-0504-196 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/15/2022
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIBusiness Operations
Elevate Oral Care002863526manufacture(57511-0504)

Revised: 9/2025
Document Id: 3f2c7ba3-31fd-ad52-e063-6394a90a2133
Set id: d9e462d9-f0fd-4168-e053-2995a90a95b2
Version: 2
Effective Time: 20250919
 
Elevate Oral Care