Label: HELLO ACTIVATED CHARCOAL- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-678-10
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Monofluorophosphate 0.76% (0.14% 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

    glycerin, water, hydrated silica, sorbitol, xylitol, erythritol, charcoal powder, flavor, xanthan gum, sodium bicarbonate, sodium cocoyl glutamate, potassium citrate, cocamidopropyl betaine, cocos nucifera (coconut) oil1,rebaudioside a1, tetrasodium pyrophosphate.

    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®

    epic
    whitening

    anticavity
    fluoride toothpaste

    activated
    charcoal

    fresh mint + coconut oil

    NET WT 4.0 OZ (113 g)

    Principal Display Panel - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HELLO ACTIVATED CHARCOAL 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-678
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ERYTHRITOL (UNII: RA96B954X6)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    Product Characteristics
    ColorBLACK (black) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-678-101 in 1 CARTON07/01/2023
    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 DRUGM02107/01/2023
    Labeler - Colgate-Palmolive Company (001344381)
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