Label: FIREFLY BUBBLE BLAST- sodium fluoride 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 December 22, 2021

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  • Active ingredient

    Sodium fluoride 0.22%

  • Purpose

    Anticavity toothpaste

  • 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 older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
    •
    instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
    •
    supervise children as necessary until capable of using without supervision
    •
    children under 2 years of age: consult a dentist or doctor
  • Inactive ingredients

    cocamidopropyl betaine, glycerin, hydrated silica, lauryl glucoside, natural flavor, purified water, sorbitol, stevia rebaudiana extract, xanthan gum, xylitol

  • Questions?

    Toll Free: 1-866-373-7374

  • Package/Label Principal Display Panel

    FIREFLY®

    BUBBLE BLAST

    natural fluoride toothpaste

    98% naturally derived

    nickelodeon

    SpongeBob SQUAREPANTS

    Fights Cavities

    NO ARTIFICIAL FLAVORS, DYES OR SWEETENERS

    NO SLS/SULFATES

    NET WT 4.2 oz (119 g)

    3+

    firefly-natural-fluoride-toothpaste-spongebob
  • INGREDIENTS AND APPEARANCE
    FIREFLY BUBBLE BLAST 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-006
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66923-006-00119 g in 1 TUBE; Type 0: Not a Combination Product04/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/08/2021
    Labeler - Ranir LLC (364567615)
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