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 Fluoride Toothpaste

Warnings

Do not swallow. Keep out of reach of children under 6 years of age. Read instructions and prescribing information before using product.

Label and instruction 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
Product Characteristics
ColorwhiteScore    
ShapeROUNDSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0504-196 g in 1 TUBE; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2020
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIBusiness Operations
Elevate Oral Care002863526manufacture(57511-0504)

Revised: 9/2020
Document Id: ae45ae2d-a220-0a05-e053-2995a90a4d5e
Set id: ae45ae2d-a21f-0a05-e053-2995a90a4d5e
Version: 1
Effective Time: 20200901
 
Elevate Oral Care