Label: FIREFLY PEDIATRIC- sodium monofluorophosphate paste

  • 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 November 9, 2021

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  • 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

  • PRINCIPAL DISPLAY PANEL

    FireFlyKitFront
    FireFlyKitBack
    FireFlyToothpasteLabel
    FireFlyToothpasteLabel2
    PouchLabel
    Pouch
  • INGREDIENTS AND APPEARANCE
    FIREFLY PEDIATRIC 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64893-802
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SACCHARIN (UNII: FST467XS7D)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64893-802-001 in 1 POUCH08/17/2011
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/17/2011
    Labeler - Dr. Fresh, LLC (117376803)
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