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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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)