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

  • NDC Code(s): 66467-3790-1
  • Packager: Darby Dental Supply, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 9, 2020

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  • DESCRIPTION

    Darby 9529100 Strawberry

    Topical Fluoride Foam

    2.72% Topical Sodium Fluoride Foam

    1.23% fluoride ions

    4.4 oz (125 g)

    NDC 66467-3790-1

  • DOSAGE & ADMINISTRATION

    A topical anti-caries preparation.

    Directions:

    1. Following prophylaxis treatment, fill 1/4 of tray with foam

    2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray

    3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes

    4. Remove tray and have patient expectorate excess

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

    Medicinal ingredients:

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

  • INACTIVE INGREDIENT

    Non-Medicinal Ingredients: Cocamidopropyl betaine, sodium phosphate monobasic, poloxamer 407, sucralose, xylitol, purified water, strawberry flavor

  • WARNINGS AND PRECAUTIONS

    Warnings:

    KEEP OUT OF REACH OF CHILDREN

    For professional use only. Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 104°F (40°C). Contents under pressure. Do not puncture and incinerate.

    Do not use if seal is broken.

  • SPL UNCLASSIFIED SECTION

    Made in the USA

    Distributed by: Darby Dental Supply, LLC, Jericho, NY 11753

    UPC 9529100

    Rev.02

  • PRINCIPAL DISPLAY PANEL

    9529100 Full Label

  • INGREDIENTS AND APPEARANCE
    DARBY  TOPICAL SODIUM FLUORIDE STRAWBERRY
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-3790
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66467-3790-1125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/31/201212/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/31/201212/31/2021
    Labeler - Darby Dental Supply, LLC (825137818)
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