Label: HELLO NATURALLY WHITENING- sodium monofluorophosphate paste, dentifrice
HELLO ACTIVATED CHARCOAL- sodium monofluorophosphate 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 October 2, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • 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 physician
  • Inactive ingredients

    sorbitol, purified water, hydrated silica, glycerin, xylitol, charcoal powder, flavor, xanthan gum, titanium dioxide, coconut oil, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by Hello Products LLC Montclair, NJ 07042

  • PRINCIPAL DISPLAY PANEL - 133 g Tube Label

    hello®

    naturally
    whitening*
    fluoride toothpaste

    farm grown mint
    with tea tree + coconut oil

    NET WT4.7 OZ (133g)

    Principal Display Panel - 133 g Tube Label
  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    hello®

    activated charcoal
    with fresh mint + coconut oil

    epic whitening
    fluoride toothpaste

    NET WT 4.0 OZ (113g)

    Principal Display Panel - 113 g Tube Label
  • INGREDIENTS AND APPEARANCE
    HELLO   NATURALLY WHITENING
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6100
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (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)  
    Xylitol (UNII: VCQ006KQ1E)  
    Glycerin (UNII: PDC6A3C0OX)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55882-6100-11 in 1 BOX10/05/2018
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:55882-6100-228 g in 1 TUBE; Type 0: Not a Combination Product10/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35510/05/2018
    HELLO   ACTIVATED CHARCOAL
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6101
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (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)  
    Xylitol (UNII: VCQ006KQ1E)  
    Glycerin (UNII: PDC6A3C0OX)  
    Activated Charcoal (UNII: 2P3VWU3H10)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Product Characteristics
    ColorBLACKScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55882-6101-11 in 1 BOX10/05/2018
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:55882-6101-228 g in 1 TUBE; Type 0: Not a Combination Product10/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35510/05/2018
    Labeler - Hello Products LLC (040714890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead126440440MANUFACTURE(55882-6100, 55882-6101)