Label: DARBY TOPICAL SODIUM FLUORIDE- sodium fluoride gel

  • NDC Code(s): 66467-2150-1
  • Packager: Darby Dental Supply Co Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/10

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Darby 60 Sec Fluoride Gel

    952-1547

    2.72 % Topical Sodium Fluoride Gel

    60 Second Application (1.23 % fluoride ions)

    Grape

    16.23 fl oz / 480mL

    NDC 66467-2150-1

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  • DOSAGE & ADMINISTRATION


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

    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: Carboxy methyl cellulose, phosphoric acid, purified water, saccharin sodium (anhydrous), titanium dioxide, red 33, blue 1, grape flavor

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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. Close
  • SPL UNCLASSIFIED SECTION

    Made in USA

    Distributed by:

    Darby Dental Supply, LLC

    Jericho, NY 11753

    UPC 952-1547

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  • INGREDIENTS AND APPEARANCE
    DARBY   TOPICAL SODIUM FLUORIDE
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66467-2150
    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 purple Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66467-2150-1 480 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/12/2010
    Labeler - Darby Dental Supply Co Inc (825137818)
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