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Denti-Care Denti-Foam (AR Medicom Inc)

Available Formats

Dosage Form Package Information Links
AEROSOL, FOAM 125 g in 1 BOTTLE, SPRAY (64778-0373-1) Label Information

Complete Denti-Care Denti-Foam Information

  • General Information

    AMD Medicom

    DentiCare Pro-Foam

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

    Bubble Gum

    4.4 oz / 125 g

    NDC 64778-0373-1

    NPN 80009738

    Rx Only in US

    Item code 10037-BG


  • Indications and Directions

    Indications: Topical anti-caries preparation

    Directions:

    1. Following prophylaxis treatment, fill ¼ of tray with foam
    2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray
    3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes
    4. remove tray and have patient expectorate excess

    Advise patient not to eat, drink or rinse for 30 minutes after the treatment

    Medicinal ingredients: Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)


  • Non-Medicinal Ingredients

    purified water, sucralose, sodium phosphate monobasic, xylitol, cocamidopropyl betaine, poloxamer 407, bubblegum flavour


  • Warnings

    KEEP OUT OF REACH OF CHILDREN. For professional use only

    Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40°C or 104°F

    Contents under pressure. Do not puncture and incinerate

    Do not use if seal is broken


  • Contact Information

    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 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 0.0272 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:64778-0373-3 12 in 1 CASE 12/01/2017
    1 NDC:64778-0373-1 125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2003
    Labeler - AMD Medicom Inc. (256880576)
    Registrant - AMD Medicom Inc. (256880576)