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

  • NDC Code(s): 55882-6100-1, 55882-6100-2, 55882-6101-1, 55882-6101-2
  • Packager: Hello Products LLC
  • 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

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  • Active Ingredient

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

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  • Purpose

    Anticavity

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  • Use

    helps protect against cavities

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  • 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.

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  • 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
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  • 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

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  • Questions?

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

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  • SPL UNCLASSIFIED SECTION

    Distributed by Hello Products LLC Montclair, NJ 07042

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  • 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
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  • 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
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  • INGREDIENTS AND APPEARANCE
    HELLO   NATURALLY WHITENING
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55882-6100
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) fluoride ion 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55882-6100-1 1 in 1 BOX 10/05/2018
    1 133 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:55882-6100-2 28 g in 1 TUBE; Type 0: Not a Combination Product 10/05/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 10/05/2018
    HELLO   ACTIVATED CHARCOAL
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55882-6101
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) fluoride ion 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color BLACK Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55882-6101-1 1 in 1 BOX 10/05/2018
    1 113 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:55882-6101-2 28 g in 1 TUBE; Type 0: Not a Combination Product 10/05/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 10/05/2018
    Labeler - Hello Products LLC (040714890)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 MANUFACTURE(55882-6100, 55882-6101)
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