Label: HELLO 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 January 27, 2023

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  • 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, purified water, hydrated silica, glycerin, xylitol, charcoal powder, flavor, xanthan gum, titanium dioxide, cocos nucifera (coconut) oil1, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract1

    1
    certified organic
  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Dist. by Hello Products LLC
    Montclair, NJ 07042

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    naturally
    friendly™
    hello®

    activated charcoal
    with fresh mint + coconut oil

    epic whitening
    fluoride toothpaste

    noticeably whiter teeth
    prevents cavities
    safe for enamel
    awesome fresh breath

    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 Carton
  • INGREDIENTS AND APPEARANCE
    HELLO CHARCOAL 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-3455
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    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
    ColorBLACK (black) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55882-3455-11 in 1 CARTON09/10/202012/30/2024
    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 FINALpart35509/10/202012/30/2024
    Labeler - Hello Products LLC (040714890)
    Registrant - Colgate-Palmolive Company (001344381)
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