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Darby Topical Fluoride Foam: Package Insert / Prescribing Info

Package insert / product label
Generic name: sodium fluoride
Dosage form: aerosol, foam
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Dec 12, 2024.

Darby 9529102 Mint

Topical Fluoride Foam

2.72% Topical Sodium Fluoride Foam

1.23% fluoride ions

4.4 oz (125 g)

NDC 66467-3760-1


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, mint 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 9529102

Rev.02

9529102 Full Label

DARBY TOPICAL SODIUM FLUORIDE MINT
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-3760
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
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-3760-1125 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)