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

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 3, 2019

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  • DESCRIPTION

    AMD Medicom Inc.

    DentiCare Pro-Foam

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

    Raspberry

    4.4 oz / 125 g

    NDC 64778-0378-1

    NPN 80009738

    Rx Only in US

    Item code 10037-RB

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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

    Water, sucralose, sodium phosphate, xylitol, betaine, pluronic, raspberry flavor

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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

    Made in USA for AMD Medicom Inc.
    2555 Chemin de l’Aviation
    Pointe-Claire, Montreal, Quebec, Canada
    H9P 2Z2

    Questions: 1-800-361-2862

    www.medicom.com

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  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE RASPBERRY
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0378
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.0272 g  in 1 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64778-0378-1 125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2005 12/31/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2005 12/31/2020
    Labeler - AMD Medicom Inc (256880576)
    Registrant - AMD Medicom Inc. (256880576)
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