Label: FLUORIMAX 5000- 1.1% sodium fluoride toothpaste paste, dentifrice

  • NDC Code(s): 57511-0504-1, 57511-0504-2
  • Packager: Elevate Oral Care
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 10, 2022

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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