ALLDAY 5000- 1.1% sodium fluoride toothpaste paste, dentifrice

Allday 5000 by

Drug Labeling and Warnings

Allday 5000 by is a Prescription medication manufactured, distributed, or labeled by Elevate Oral Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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

Instructions for Use

Package Label

INGREDIENTS AND APPEARANCE

ALLDAY 5000 
1.1% sodium fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57511-0005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (white paste)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57511-0005-1	2 in 1 BOX	05/31/2022
1		1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/31/2022

Labeler - Elevate Oral Care (002863526)

Registrant - Elevate Oral Care (002863526)

Establishment
Name	Address	ID/FEI	Business Operations
Elevate Oral Care		002863526	manufacture(57511-0005)