Label: HELLO VITAMIN C WHITENING- sodium fluoride paste, dentifrice

  • NDC Code(s): 35000-689-10
  • Packager: Colgate-Palmolive Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (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
    chldren 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

    water, hydrated silica, sorbitol, glycerin, xylitol, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium ascorbyl phosphate (vitamin c), flavor, cellulose gum, sodium cocoyl glutamate, cocamidopropyl betaine, xanthan gum, rebaudioside a, annatto1.

    1
    natural annatto pigment provides orange color
  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Dist. by Colgate-Palmolive Co.
    New York, NY 10022

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    hello®

    vitamin c
    whitening

    2 shades whiter*

    C
    the
    sparkle

    natural peppermint

    anticavity fluoride toothpaste

    NET WT 4.0 OZ (113 g)

    Principal Display Panel - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HELLO VITAMIN C WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-689
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    ANNATTO (UNII: 6PQP1V1B6O)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-689-101 in 1 CARTON01/01/2024
    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 drugM02101/01/2024
    Labeler - Colgate-Palmolive Company (001344381)
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