Label: FIREFLY STRAWBERRY SMOOTHIE- 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 0.24%

  • 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®

    STRAWBERRY SMOOTHIE

    fluoride toothpaste

    PROTECTS AGAINST CAVITIES

    LOL SURPRISE™

    98% naturally derived

    NO ARTIFICIAL SWEETENERS

    NO ARTIFICIAL FLAVORS

    NO DYES

    NO SLS/SULFATES

    98% naturally derived

    NET WT 4.2 oz (119 g)

    3+

    firefly-fluoride-toothpaste
  • INGREDIENTS AND APPEARANCE
    FIREFLY STRAWBERRY SMOOTHIE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 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
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66923-005-00119 g in 1 TUBE; Type 0: Not a Combination Product03/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/25/2021
    Labeler - Ranir LLC (364567615)
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