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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Darby 60 Sec Gel 2.72 % Topical Sodium Fluoride Gel Watermelon

Darby 60 Sec Fluoride Gel

952-1544

2.72 % Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Watermelon

16.23 fl oz / 480mL

NDC 66467-2120-1


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

Directions:

1. Use after thorough prophylaxis

2. To dispense, fill tray(s) 1/3 with gel

3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds

4. Remove tray(s) and have patient expectorate excess

5. 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)

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 40 degrees C or 104 degrees F.

Do not use if seal is broken.

Made in USA

Distributed by:

Darby Dental Supply, LLC

Jericho, NY 11753

UPC 952-1544

Rev.00

952-1544
DARBY  TOPICAL SODIUM FLUORIDE
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66467-2120
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
ColorpinkScore    
ShapeSize
FlavorWATERMELONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66467-2120-1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/201004/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/17/201004/12/2017
Labeler - Darby Dental Supply, LLC (825137818)

Revised: 4/2017
 
Darby Dental Supply, LLC