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

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.

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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

JR5kCake Label

JUST RIGHT 5000 
1.1% sodium fluoride toothpaste gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57511-0119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN (UNII: FST467XS7D)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
Product Characteristics
Colorwhite (off white) Score    
ShapeROUNDSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0119-891 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
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/FEIBusiness Operations
Elevate Oral Care002863526manufacture(57511-0119)

Revised: 2/2018
Document Id: 728ce5e0-c60e-1364-e053-2a91aa0a3e2d
Set id: 5aa80253-a729-26fc-e053-2a91aa0adc23
Version: 6
Effective Time: 20180207
 
Elevate Oral Care