Label: DENTI-CARE TOPICAL FLUORIDE FOAM GRAPE- fluoride ions aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 64778-1375-1 - Packager: AR Medicom Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 9, 2011
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- Official Label (Printer Friendly)
- DESCRIPTION
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DOSAGE & ADMINISTRATION
A topical anti-caries preparation
Directions (for professional use only):
1. Use after thorough prophylaxis
2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)
Note: fill tray(s) at one quarter full to allow foam to expand
3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes
4. Remove tray(s) and have patient expectorate excess
5. Advise patient not to eat, drink or rinse for 30 minutes after the application
130 applications
Medicinal ingredients:
Fluoride ions 1.23 % w/w (from 1.76 % sodium fluoride and 1.04% hydrofluoric acid)
- INACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTI-CARE TOPICAL FLUORIDE FOAM GRAPE
fluoride ions aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-1375 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) sodium fluoride .0176 g in 1 g HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) HYDROFLUORIC ACID 0.010 g in 1 g Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64778-1375-1 125 g in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2003 Labeler - AR Medicom Inc (247876295)