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 Toothpaste Spearmint

Warnings

WARNINGS: Do not swallow. Keep out of reach of children under 12 yeaars of age. Read all instructions and prescribing information before using this product. Don't freeze or expose to extreme heat.

Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Package Label and Instructions for use

Primary Package Label

FLUORIMAX 5000 SENSITIVE 
1.1% sodium fluoride with 5% potassium nitrate toothpaste paste, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57511-0503
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
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN (UNII: FST467XS7D)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScore    
ShapeROUNDSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0503-22 in 1 BOX06/15/2022
1NDC:57511-0503-196 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(57511-0503)

Revised: 3/2022
Document Id: d9f232c0-d155-536b-e053-2995a90af37d
Set id: d9f232c0-d154-536b-e053-2995a90af37d
Version: 1
Effective Time: 20220311
 
Elevate Oral Care