DARBY TOPICAL SODIUM FLUORIDE- sodium fluoride gel 
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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9521530 Mint
Darby 60 Second Fluoride Gel
2.72 % Topical Sodium Fluoride Gel Mint

Darby 9521530 Mint

60 Second Fluoride Gel

2.72% Topical Sodium Fluoride Gel

1.23% fluoride ions

16.23 fl oz (480 ml)

NDC 66467-2160-1

A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavored.

Directions:

1. Following prophylaxis treatment, fill 1/3 of tray with gel

2. Insert tray in the patient's mouth, have patient bite down lightly for 60 seconds

3. Remove tray and have patient expectorate excess

4. Advise patient not to eat, drink or rinse for 30 minutes after the application

Medicinal ingredients:

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

Non-Medicinal Ingredients: Carboxy methyl cellulose, phosphoric acid, purified water, saccharin sodium, titanium dioxide, blue 1, yellow 5, peppermint oil, spearmint oil

.

Warnings:

KEEP OUT OF REACH OF CHILDREN.

For professional use only. Do not swallow.

Not recommended for use by children under 18 months of age.

Store at room temperature. Do not expose to excessive heat over 104°F (40°C).

Do not use if seal is broken.

Made in the USA

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

UPC 9521530

Rev.02

9521530 Full Label

DARBY  TOPICAL SODIUM FLUORIDE
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2160
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 mL
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2160-1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/18/201008/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/18/201008/31/2020
Labeler - Darby Dental Supply, LLC (825137818)

Revised: 12/2020
 
Darby Dental Supply, LLC