JUST RIGHT 5000- 1.1% sodium fluoride toothpaste gel, dentifrice

Just Right 5000 by

Drug Labeling and Warnings

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

Drug Details [pdf]

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, Xylitol, Glycerin, Hydrated silica, PEG-8, Caramel Apple Flavor, Sodium Lauryl Sulfate, Xanthan Gum, Potassium Phosphate, Sodium Benzoate, Sodium Saccharin, Mica, FD&C Red 40

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

INGREDIENTS AND APPEARANCE

JUST RIGHT 5000 
1.1% sodium fluoride toothpaste gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57511-0122
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
MICA (UNII: V8A1AW0880)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN (UNII: FST467XS7D)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	blue	Score
Shape	ROUND	Size
Flavor	APPLE (and Caramel)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57511-0122-8	97 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2020

Labeler - Elevate Oral Care (002863526)

Registrant - Elevate Oral Care (002863526)

Establishment
Name	Address	ID/FEI	Business Operations
Elevate Oral Care		002863526	repack(57511-0122)