Label: HELLO MAGICAL MERMAID- sodium fluoride gel, dentifrice

  • NDC Code(s): 35000-680-10
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 19, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sodium fluoride 0.24% (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, sorbitol, water, hydrated silica, erythritol, xylitol, xanthan gum, sodium bicarbonate, lauryl glucoside, potassium citrate, tetrasodium pyrophosphate, rebaudioside a, flavor.

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Dist. by Hello Products LLC Montclair, NJ 07042

  • PRINCIPAL DISPLAY PANEL - 119 g Tube Label

    hello®

    magical mermaid
    anticavity fluoride toothpaste

    tastes magical
    works brilliantly

    orange dreamsicle
    natural flavor

    NET WT 4.2 OZ (119 g)

    PRINCIPAL DISPLAY PANEL - 119 g Tube Label
  • INGREDIENTS AND APPEARANCE
    HELLO MAGICAL MERMAID 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-680
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-680-10119 g in 1 TUBE; Type 0: Not a Combination Product07/01/2023
    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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