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: Do not swallow. Keep out of reach of children under 6 years of age. Read all instructions and prescribing information before using this product. Do not freeze or expose to extreme heat.

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)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
SACCHARIN (UNII: FST467XS7D)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
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: 3/2022
Document Id: d9e462d9-f0fe-4168-e053-2995a90a95b2
Set id: d9e462d9-f0fd-4168-e053-2995a90a95b2
Version: 1
Effective Time: 20220310
 
Elevate Oral Care