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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 8, 2021

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  • Warning

    Do not swallow. Keep out of reach of children under 6 years of age. Read all instructions and prescribing information before using this product. Do not freeze or expose to extreme heat.

  • Package label and instruction for use

    Primary package label

  • INGREDIENTS AND APPEARANCE
    JUST RIGHT 5000 
    1.1% sodium fluoride toothpaste gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57511-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 g  in 100 g
    Product Characteristics
    ColorredScore    
    ShapeROUNDSize
    FlavorAPPLE (Candy Apple) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57511-0002-197 g in 1 TUBE; Type 0: Not a Combination Product08/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/28/2020
    Labeler - Elevate Oral Care (002863526)
    Registrant - Elevate Oral Care (002863526)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elevate Oral Care002863526manufacture(57511-0002)