Skip to Content

Darby Topical Fluoride Bubble Gum

Generic name: sodium fluoride
Dosage form: aerosol, foam
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Dec 1, 2020.

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.

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

DARBY TOPICAL SODIUM FLUORIDE BUBBLE GUM
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66467-3730
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g in 1 g
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:66467-3730-1 125 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 11/30/2021
Labeler - Darby Dental Supply, LLC (825137818)
Darby Dental Supply, LLC