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Just Right 5000 by Elevate Oral Care

Medically reviewed on January 31, 2018

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 1.1mg in 1mg
Labeler: Elevate Oral Care
NDC Code: 57511-0120

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Just Right 5000 - Bubble Mint

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

JUST RIGHT 5000 
1.1% sodium fluoride toothpaste gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0120
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
FD&C BLUE NO. 1 
SACCHARIN 
POTASSIUM PHOSPHATE, MONOBASIC 
XANTHAN GUM 
Product Characteristics
ColorblueScore    
ShapeROUNDSize
FlavorBUBBLE GUM (and Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:57511-0120-891000 mg 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(57511-0120)

 
Elevate Oral Care

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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