Label: DARBY TOPICAL SODIUM FLUORIDE GRAPE- sodium fluoride aerosol, foam

  • NDC Code(s): 66467-3750-1
  • Packager: Darby Dental Supply Co
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/11

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

  • DESCRIPTION

    Darby 2.72 % Topical Sodium Fluoride Foam

    (1.23 % Fluoride Ions)

    Grape

    4.4 oz / 125 g

    NDC 66467-3750-1


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  • DOSAGE & ADMINISTRATION


    A topical anti-caries preparation

    Directions (for professional use only):

    1. Use after thorough prophylaxis

    2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

    Note: fill tray(s) at one quarter full to allow foam to expand

    3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

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

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

    130 applications

    Medicinal ingredients:

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




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  • INACTIVE INGREDIENT


    Non-Medicinal ingredients: cocamidopropyl betaine, sodium phosphate, poloxamer 407, sucralose, xylitol, purified water, grape flavour
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  • WARNINGS AND PRECAUTIONS

    Warnings: KEEP OUT OF REACH OF CHILDREN

    Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

    Do not use if seal is broken.

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  • SPL UNCLASSIFIED SECTION


    Made in USA
    Distributed by:
    Darby Dental Supply, LLC
    Jericho, Ny11753
    UPC 952-9103
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  • INGREDIENTS AND APPEARANCE
    DARBY   TOPICAL SODIUM FLUORIDE GRAPE
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66467-3750
    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 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66467-3750-1 125 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/31/2012
    Labeler - Darby Dental Supply Co (825137818)
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