ALLDAY 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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Allday 5000 1.1% Sodium Fluoride Toothpaste, Spearmint

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

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)

Revised: 2/2024
Document Id: 11e5ebc1-d0c3-32d1-e063-6394a90a3991
Set id: d92b84db-2202-33cc-e053-2a95a90a1753
Version: 2
Effective Time: 20240221
 
Elevate Oral Care