DARBY TOPICAL SODIUM FLUORIDE BUBBLE GUM- sodium fluoride aerosol, foam 
Darby Dental Supply, LLC

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.

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9529104 Bubble Gum
Darby Topical Fluoride Foam
2.72% Topical Sodium Fluoride Foam

Darby 9529104 Bubble Gum

Topical Fluoride Foam

2.72% Topical Sodium Fluoride Foam

1.23% fluoride ions

4.4 oz (125 g)

NDC 66467-3730-1


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)

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

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.

Made in the USA

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

UPC 9529104

Rev.02

9529104 Full Label

DARBY  TOPICAL SODIUM FLUORIDE BUBBLE GUM
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-3730
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
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-3730-1125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/31/201211/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/31/201211/30/2021
Labeler - Darby Dental Supply, LLC (825137818)

Revised: 12/2020
 
Darby Dental Supply, LLC