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Just Right 5000

Medically reviewed by Drugs.com. Last updated on Jan 28, 2020.

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 1.11g in 100g
Labeler: Elevate Oral Care
NDC Code: 57511-0119

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Just Right 5000 - Cake Frosting

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, Vanilla Flavor, Sodium Lauryl Sulfate, Xanthan Gum, Potassium Phosphate, Sodium Benzoate, Sodium Saccharin, Mica,

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

JUST RIGHT 5000 
1.1% sodium fluoride toothpaste gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0119
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE1.11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
TITANIUM DIOXIDE 
SACCHARIN 
XANTHAN GUM 
POTASSIUM PHOSPHATE, MONOBASIC 
Product Characteristics
Colorwhite (off white) Score    
ShapeROUNDSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57511-0119-891 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2018
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIOperations
Elevate Oral Care002863526manufacture(57511-0119)

 
Elevate Oral Care