Label: DENTI-CARE TOPICAL FLUORIDE FOAM GRAPE- fluoride ions aerosol, foam

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 9, 2011

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  • DESCRIPTION

    Denti-Care

    Denti-Foam

    Topical Fluoride Foam Grape

    1.23 % Fluoride Ions

    4.4 oz / 125 g

    NDC 64778-1375-1


  • DOSAGE & ADMINISTRATION



    A topical anti-caries preparation

    Directions (for professional use only):

    1. Use after thorough prophylaxis

    2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

    Note: fill tray(s) at one quarter full to allow foam to expand

    3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

    4. Remove tray(s) and have patient expectorate excess

    5. Advise patient not to eat, drink or rinse for 30 minutes after the application

    130 applications

    Medicinal ingredients:

    Fluoride ions 1.23 % w/w (from 1.76 % sodium fluoride and 1.04% hydrofluoric acid)



  • INACTIVE INGREDIENT

    Non-Medicinal ingredients: sodium saccharin, sodium benzoate, plasdone C30, glycerin USP, propylene glycol, polysorbate 20, stepanol WA 100, phosphoric acid, purified water, grape flavor
  • WARNINGS AND PRECAUTIONS

    Warnings: KEEP OUT OF REACH OF CHILDREN

    Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

    Do not use if seal is broken.

    Rx Only
  • SPL UNCLASSIFIED SECTION

    Manufactured in Canada for
    AR Medicom Inc
    Montreal, Canada, H8T 3J8
    Questions 1-800-361-2862 or www.medicom.com
    UPC 686864008675
    Item code 10037-GR
    Rev 00
  • PRINCIPAL DISPLAY PANEL

    10037foamg

  • INGREDIENTS AND APPEARANCE
    DENTI-CARE  TOPICAL FLUORIDE FOAM GRAPE
    fluoride ions aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-1375
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) sodium fluoride.0176 g  in 1 g
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) HYDROFLUORIC ACID0.010 g  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64778-1375-1125 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2003
    Labeler - AR Medicom Inc (247876295)
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