Label: DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE BUBBLE GUM- sodium fluoride aerosol, foam

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

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Drug Label Information

Updated February 25, 2010

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  • DESCRIPTION

    Medicom

    Denti-Care

    Denti-Foam

    2.72 % Topical Sodium Fluoride Foam (1.23 % Fluoride Ions)

    Bubblegum

    4.4 oz / 125 g

    NDC 64778-0373-1

    NPN 80009738

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  • 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 2.72 % w/w sodium fluoride)



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  • INACTIVE INGREDIENT

    Non-Medicinal ingredients: cocamidopropyl betaine, phosphoric acid, poloxamer 407, sucralose, tartaric acid, xylitol, purified water, bubblegum flavour

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  • 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 (in US only)

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  • SPL UNCLASSIFIED SECTION

    Manufactured in USA for AR Medicom Inc., Montreal, Canada, H8T 3J8

    Questions 1-800-361-2862 or www.medicom.com

    UPC 686864008668

    No. 112479

    Item Code 10037-BG

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  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE BUBBLE GUM
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0373
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion .0272 g  in 1 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64778-0373-1 125 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2003
    Labeler - AR Medicom Inc (247876295)
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