Label: HELLO ACTIVATED CHARCOAL PLUS MATCHA GREEN TEA EPIC WHITENING FLUORIDE- 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 June 16, 2020

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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 yearsask a dentist or physician
  • Inactive ingredients

    sorbitol, hydrated silica, vegetable glycerin, xylitol, purified water, charcoal powder, flavor, xanthan gum, titanium dioxide, camellia sinensis (matcha) leaf extract, cocos nucifera (coconut) oil, 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 - 113 g Tube Box

    naturally
    friendly
    hello®

    activated charcoal +
    matcha green tea

    farm grown mint

    epic whitening
    fluoride toothpaste

    noticeably whiter teeth
    removes plaque
    prevents cavities
    excites tastebuds

    never tested
    on animals

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

    NET WT 4.0 OZ (113g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Box
  • INGREDIENTS AND APPEARANCE
    HELLO   ACTIVATED CHARCOAL PLUS MATCHA GREEN TEA EPIC WHITENING FLUORIDE
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6105
    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)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Product Characteristics
    ColorBLACKScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55882-6105-11 in 1 BOX12/01/2019
    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 FINALpart35512/01/2019
    Labeler - Hello Products LLC (040714890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418MANUFACTURE(55882-6105)