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Denti-Care Denti-Pro (AR Medicom Inc)

Available Formats

Dosage Form Package Information Links
GEL 480 mL in 1 BOTTLE, PLASTIC (64778-0213-1) Label Information

Complete Denti-Care Denti-Pro Information

  • General Information

    AMD Medicom Inc.

    DentiCare Pro-Gel

    2.72 % Topical Sodium Fluoride Gel

    60 Second Application (1.23 % fluoride ions)

    Bubble Gum

    16.23 fl oz / 480mL

    NDC 64778-0213-1

    NPN 80008336

    RX only in US

    Item code 10021-BG


  • Indications and Directions

    Indications: Topical anti-carie preparation

    Directions:

    1. Following prophylaxis treatment, fill 1/3 of tray with gel
    2. Insert tray in the patient’s mouth
    3. Have patient bite down lightly for 60 seconds
    4. Remove tray and have patient expectorate excess.

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

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


  • Non-Medicinal Ingredients

    Carboxymethylcellulose sodium, phosphoric acid, purifed water, saccharin sodium, titanium dioxide, red 33, bubble gum flavour


  • Warnings

    KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for children under 18 months of age

    Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF

    Do not use if seal is broken


  • Contact Information


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

    Questions: 1-800-361-2862


    www.medicom.com


  • Principal Display Panel

    Principal Display Panel





  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0213
    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 mL
    Product Characteristics
    Color pink Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64778-0213-3 12 in 1 CASE 12/01/2017
    1 NDC:64778-0213-1 480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/01/1999
    Labeler - AMD Medicom Inc. (256880576)
    Registrant - AMD Medicom Inc. (256880576)