Label: HELLO NATURALLY WHITENING- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 35000-682-10
  • 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, calcium carbonate, sorbitol, erythritol, xylitol, flavor, xanthan gum, sodium bicarbonate, potassium citrate, sodium cocoyl glutamate, cocamidopropyl betaine, cocos nucifera (coconut) oil, rebaudioside a1, melaleuca alternifolia (tea tree) leaf oil.

    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 - 133 g Tube Carton

    naturally
    friendly®
    hello®

    naturally
    whitening*

    anticavity
    fluoride toothpaste

    mint
    to be

    farm grown mint + coconut oil
    NET WT 4.7 OZ (133 g)

    PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HELLO NATURALLY WHITENING 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-682
    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)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITOL (UNII: 506T60A25R)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-682-101 in 1 CARTON07/01/2023
    1133 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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