Home > Drugs A-Z > Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse

Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse (Dr. Fresh, Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 44 mL in 1 TUBE (64893-300-00) Label Information
LIQUID 473 mL in 1 TUBE (64893-300-01) Label Information

Complete Firefly Mouth Swoosh Anti-Cavity Fluoride Rinse Information

  • ACTIVE INGREDIENT

    Active ingredient                                                                    
    Sodium fluoride 0.05% (0.02% w/v fluoride ion).........................


  • PURPOSE

    Purpose: Anticavity Rinse


  • INDICATIONS & USAGE

    Uses - Aids in the prevention of dental cavities


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.


  • WARNINGS

    Warnings

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


  • DOSAGE & ADMINISTRATION

    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 untill capable of using without supervision. - Children under 6 years of age: Consult a dentist or doctor.


  • STORAGE AND HANDLING

    Other information Store at room temperature


  • INACTIVE INGREDIENT

    Inactive ingredients
    Cetylpyridinium chloride, citric acid, disodium EDTA, disodium phosphate, Bubble Gum Flavor, polysorbate 80, propylene glycol, FDandC Red No. 33, sodium benzoate, sodium phosphate monobasic, sodium saccharin, sorbitol, water, xylitol.


  • QUESTIONS

    DR.Fresh

    Question? Comments?

    Toll Free. 1-866-373-7374

    comments@defresh.com

    visit us online at:

    www.drfresh.com


  • DESCRIPTION

    Distributed by:

    USA - Dr. Fresh Inc.

    Buena Park, CA 90620 USA

    Canada - Dr. Fresh Inc. Ontario,

    Canada L7C2T4

    UK - Grosvenor Consumer Products Limited

    25 Gore Road, Burnham Bucks SL1 8AB

    www.firefly.us.com

    FireFly* and related trademark, names, logos, and patents are the property of Dr.Fresh, Inc. and are registered and/or used in the U.S. and countries around the world.

    2010 Dr. Fresh, Inc.

    Patent Pending

    Made in U.S.A.


  • PRINCIPAL DISPLAY PANEL

    Do not use if carton is open or if printed foil seal underneath tube cap is missing or broken.

    FIREFLY MOUTHSWOOSH

    Anti-Cavity Fluoride Rinse

    BLAZIN Bubble Gum Flavor

    16 fl oz (473 mL)

    IMPORTANT:

    Read directions for proper use.

    - Sugar-Free

    - Alcohol-Free

    - With Fluoride


    Made in U.S.A.

  • INGREDIENTS AND APPEARANCE
    FIREFLY MOUTH SWOOSH ANTI-CAVITY FLUORIDE RINSE 
    sodium fluoride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64893-300
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM FLUORIDE 0.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64893-300-00 44 mL in 1 TUBE
    2 NDC:64893-300-01 473 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/02/2010
    Labeler - Dr. Fresh, Inc. (033059119)
    Establishment
    Name Address ID/FEI Business Operations
    Dr. Fresh, Inc. 033059119 manufacture