Label: DARBY TOPICAL SODIUM FLUORIDE STRAWBERRY- sodium fluoride aerosol, foam
- NDC Code(s): 66467-3790-1
- Packager: Darby Dental Supply, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 9, 2020
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- Official Label (Printer Friendly)
- DESCRIPTION
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DOSAGE & ADMINISTRATION
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)
- INACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DARBY TOPICAL SODIUM FLUORIDE STRAWBERRY
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66467-3790 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.0272 g in 1 g Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66467-3790-1 125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/31/2012 12/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/31/2012 12/31/2021 Labeler - Darby Dental Supply, LLC (825137818)