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FIREFLY Pediatric (Dr. Fresh, Inc.)

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PASTE 1 TUBE in 1 POUCH (64893-802-00) > 28 g in 1 TUBE Label Information

Complete FIREFLY Pediatric Information

  • ACTIVE INGREDIENT

    Active Ingredient                               

    Sodium Monofluorophosphate 0.76%


  • PURPOSE

    Purpose
    Anti-Cavity Toothpaste

  • INDICATIONS & USAGE

    Use: Helps prevent against cavities


  • KEEP OUT OF REACH OF CHILDREN

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


  • WARNINGS

    Warnings: If you accidentally swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.


  • DOSAGE & ADMINISTRATION

    Directions: adults and children 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist


  • INACTIVE INGREDIENT

    Inactive Ingredients: Sorbitol, Silica, Water, Sodium Lauryl Sulfate, Flavor, PEG-32, Mica, Sodium Carboxy Methyl Cellulose, Saccharin, Trisodium Phosphate, FDandC Blue No. 1, Calcium Glycerophosphate


  • QUESTIONS

    Questions? Call 1-866-373-7374

    www.drfresh.com


  • DESCRIPTION

    DR.Fresh

    USA - Dr.Fresh Inc.,                      CA - Dr.Fresh Inc.,

    Buena Park,CA 90620 USA          Ontario,Canada L7C2T4

    U.K. - Dr.Fresh UK LTD.                 "FireFly" and related

    Winchester House, London,           trademark are owned by

                NW1 5RA                             Dr.Fresh Inc., U.S.A


  • PRINCIPAL DISPLAY PANEL

    FIREFLY

    Kids Comply With Firefly!

    Pediatric Kit

    Premium Zip Pouch

    Contains:
    • FireFly Lightup Timer Toothbrush
    • FireFly Bubble Gum Toothpaste
    • FireFly Flossers
    • Toothbrush Cap
    Be sure to brush 1 minute on top teeth and 1 minute on bottom teeth

  • INGREDIENTS AND APPEARANCE
    FIREFLY PEDIATRIC 
    sodium monofluorophosphate paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64893-802
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.76 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN (UNII: FST467XS7D)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64893-802-00 1 in 1 POUCH
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 08/17/2011
    Labeler - Dr. Fresh, Inc. (033059119)
    Establishment
    Name Address ID/FEI Business Operations
    Changzhou Daya Imp & Exp Corp., Ltd. 421084500 manufacture