Label: DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel

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

Drug Label Information

Updated 02/10

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  • DESCRIPTION

    Medicom

    Denti-Care

    Denti-Pro 60 Sec Gel

    2.72 % Topical Sodium Fluoride Gel

    60 Second Application (1.23 % fluoride ions)

    Orange

    16.23 fl oz / 480mL

    NDC 64778-0217-1

    NPN 80008336

    Item code 10021-O

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  • DOSAGE & ADMINISTRATION

    A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavoured.

    Directions:

    1. Use after thorough prophylaxis

    2. To dispense, fill tray(s) 1/3 with gel

    3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds

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

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

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

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  • INACTIVE INGREDIENT

    Non-Medicinal ingredients: hydroxyethyl cellulose, phosphoric acid, purified water, yellow 6, saccharin sodium (anhydrous), titanium dioxide, orange flavour.

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  • WARNINGS AND PRECAUTIONS

    Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only. Do not swallow.

    Not recommended for use by children under 18 months of age.

    Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F.

    Do not use if seal is broken.

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  • SPL UNCLASSIFIED SECTION

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

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

    UPC 686864010371

    No. 112446

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  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64778-0217
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sodium fluoride (fluoride ion) fluoride ion .0272 g  in 1 mL
    Product Characteristics
    Color orange Score     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64778-0217-1 480 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/01/2000
    Labeler - AR Medicom Inc (247876295)
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