Label: HELLO JUICY GRAPE FLUORIDE- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 23, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use helps protect against cavities

  • Warnings

    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.

  • Directions

    • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    • children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    • children under 2 years: ask a dentist or a physician.
  • Inactive ingredients

    sorbitol, hydrated silica, purified water, glycerin, xylitol, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract1.

    1
    certified organic
  • Questions?

    855-HI-HELLO (1-855-444-3556)

  • SPL UNCLASSIFIED SECTION

    Distributed by Hello Products LLC Montclair, NJ 07042

  • PRINCIPAL DISPLAY PANEL - 119 g Tube Box

    naturally
    friendly™

    hello®

    fluoride toothpaste
    kids ages 2+

    juicy grape
    natural flavor

    prevents cavities
    polishes + brightens
    strengthens enamel
    tastes awesome

    not tested
    on animals

    vegan. no artificial sweeteners. no dyes.
    no SLS/sulfates. no brainer.

    NET WT 4.2 OZ (119 g)

    PRINCIPAL DISPLAY PANEL - 119 g Tube Box
  • INGREDIENTS AND APPEARANCE
    HELLO   JUICY GRAPE FLUORIDE
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6112
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55882-6112-11 in 1 BOX03/01/202112/31/2024
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35503/01/202112/31/2024
    Labeler - Hello Products LLC (040714890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418MANUFACTURE(55882-6112)
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