Label: HELLO BYE BYE BACTERIA FLUORIDE- 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 March 13, 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, calcium carbonate, erythritol, xylitol, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, cocos nucifera (coconut) oil1, sodium cocoyl glutamate, zinc citrate, 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 - 113 g Tube Carton

    seriously
    friendly™
    hello®

    bye bye
    bacteria*

    fluoride toothpaste
    with zinc + tea tree oil

    mmm, tasty
    herbal mint

    *kills bad breath bacteria

    NET WT 4.0 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HELLO   BYE BYE BACTERIA FLUORIDE
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6117
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55882-6117-11 in 1 CARTON01/03/202206/30/2024
    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 FINALpart35501/03/202206/30/2024
    Labeler - Hello Products LLC (040714890)
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