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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated March 1, 2022

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  • WARNINGS

    WARNINGS: Not for systemic treatment. DO NOT SWALLOW. Keep out of reach of children under 6 years of age.

  • Instructions for Use

    Instructions for use

  • Package Label

    Allday 5000 Box

  • INGREDIENTS AND APPEARANCE
    ALLDAY 5000 
    1.1% sodium fluoride toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57511-0005
    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
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    DIMETHICONE PEG-8 ADIPATE (UNII: 09Y0SJ39VP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white paste) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57511-0005-12 in 1 BOX05/31/2022
    11 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/31/2022
    Labeler - Elevate Oral Care (002863526)
    Registrant - Elevate Oral Care (002863526)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elevate Oral Care002863526manufacture(57511-0005)