Label: FIREFLY ANTICAVITY FLUORIDE- sodium fluoride rinse

  • 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 21, 2021

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  • Active ingredient

    Sodium Fluoride 0.05%

  • Purpose

    Anticavity rinse

  • Use

    aids in the prevention of dental cavities.

  • Warnings

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 6 years of age and older:

    •
    use once a day after brushing your teeth with a toothpaste
    •
    vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
    •
    DO NOT SWALLOW THE RINSE
    •
    do not eat or drink for 30 minutes after rinsing
    •
    instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    •
    supervise children as necessary until capable of using without supervision

    Children under 6 years of age: consult a dentist or doctor.

  • Other Information

    •
    recommended storage temperature 59°-86°F(15°-30°C)
    •
    do not use if printed plastic neckband is broken or missing
  • Inactive Ingredients

    cetylpyridinium chloride, citric acid, D&C red #33, disodium EDTA, disodium phosphate, flavor, PEG-40 hydrogenated castor oil, poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose, xylitol

  • Questions?

    Toll Free: 1-866-373-7374

  • Principal Display Panel

    FIREFLY® ANTICAVITY Fluoride Rinse

    L.O.L. SURPRISE

    WILD MELON

    Helps PREVENT CAVITIES

    ADA Accepted American Dental Association®

    Helps prevent cavities

    Alcohol FREE

    IMPORTANT: Read directions for proper use.

    16 FL OZ (473 mL)

    firefly-anticavity-fluoride-rinse-front
    firefly-anticavity-fluoride-rinse-back
  • INGREDIENTS AND APPEARANCE
    FIREFLY ANTICAVITY FLUORIDE 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-007
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66923-007-00473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/16/2021
    Labeler - Ranir LLC (364567615)
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