Label: DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE- sodium fluoride liquid

  • 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-Rinse

    2% Neutral Sodium Fluoride Oral Rinse

    Mint

    1.9 L / 64 fl oz

    NDC 64778-0446-1

    NPN 80008542

    Rx Only
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  • DOSAGE & ADMINISTRATION

    For topical application to aid in the prevention of dental caries. Neutral pH is especially safe for crowns and restorations.

    Directions:

    1. Dispense 10mL of Denti-Rinse 2% Neutral Sodium Fluoride solution into a measuring cup.

    2. Instruct patient to rinse vigorously for 1 minute with 10mL of the solution around and between teeth, and then expectorate.

    3. For maximum benefit, repeat the rinse procedure with an additional 10mL.

    4. Instruct patient not to eat, drink or rinse mouth for at least 30 minutes.

    5. Denti-Rinse solution may also be applied full strength with a cotton tip applicator to teeth isolated with cotton rolls.


    Medicinal ingredients: Sodium fluoride 2.0% w/w



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  • INACTIVE INGREDIENT

    Non-Medicinal ingredients: Citric acid (anhydrous), potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint flavour

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  • WARNINGS AND PRECAUTIONS

    Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only.

    Not recommended for use by children under 6 years of age. Do not swallow.

    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: A.R. Medicom Inc. Montreal, Canada H8T 3J8

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

    Item Code 10044-M

    UPC 686864000709

    No. 112450

    Rev.2

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  • INGREDIENTS AND APPEARANCE
    DENTI-CARE DENTI-RINSE  NEUTRAL SODIUM FLUORIDE ORAL RINSE
    sodium fluoride liquid
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64778-0446
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    sodium fluoride (fluoride ion) fluoride ion .02 g  in 1 mL
    Product Characteristics
    Color green Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64778-0446-1 1900 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/01/2001
    Labeler - AR Medicom Inc (247876295)
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