Label at a glance#

ProductJust Right 5000

Active ingredientSODIUM FLUORIDE

Label structure2 sections

Contacts and useful links#

PhoneLabel contact1-877-866-9113

Websitewww.elevateoralcare.com

www.elevateoralcare.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 1.1% Anticavity toothpaste

INDICATIONS & USAGE SECTION

helps protect against cavities

WARNINGS SECTION

Keep out of reach of children under 6 years of age: if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age:

INSTRUCTIONS FOR USE SECTION

Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients; Sorbitol, Water, Glycerin, Hydrated silica, PEG-8, Bubble Gum/Mint Flavor, Sodium Lauryl Sulfate, Xanthan Gum, Potassium Phosphate, Sodium Benzoate, Sodium Saccharin, Mica, Blue 1.1% Solution

OTC - QUESTIONS SECTION

Questions? 1-877-866-9113 or visit our website at www.elevateoralcare.com

OTC - PURPOSE SECTION

Helps protect against Cavities

DOSAGE & ADMINISTRATION SECTION

Directions: *adults and children 2 years and older: wet a toothbrush and pump once to apply a pea-sized (~0.25 gram) amount of toothpaste onto a toothbrush * brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. * to minimize swallowing, only pump once to dispense a pea-sized amount for children under 6 years. * supervise children's brushing untill good habits are established. * children under 2 years: ask dentist or physician.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JR5KBMlabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57511-0120-8	2020-01-31	C162847	48780-1	9d75b9d0-f95b-f424-e053-dadaa90a57ce	Just Right 5000 - Bubble Mint

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57511-0120	JUST RIGHT 5000 (1.1% SODIUM FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [ELEVATE ORAL CARE]	6	Legacy NDC	20190109_5aa80253-a756-26fc-e053-2a91aa0adc23.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57511-0120-9	GM - Gram	57511-0120	f64c44ef-af2a-42dc-a139-b7b10426dc07	1	2022-09-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Just Right 5000
1.1% Sodium Fluoride Toothpaste
WATER
SORBITOL
HYDRATED SILICA
GLYCERIN
FD&C BLUE NO. 1
SACCHARIN
POTASSIUM PHOSPHATE, MONOBASIC
XANTHAN GUM
SODIUM FLUORIDE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57511-0120	57511-0120-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SACCHARIN	FST467XS7D	IACT
POTASSIUM PHOSPHATE, MONOBASIC	4J9FJ0HL51	IACT
XANTHAN GUM	TTV12P4NEE	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
41473d79-0dbd-a36a-e063-6294a90a0900			5aa80253-a756-26fc-e053-2a91aa0adc23	2025-10-16	Warnings	Exact identifier spl set id: 5aa80253-a756-26fc-e053-2a91aa0adc23

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.