Label: DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE RASPBERRY- sodium fluoride aerosol, foam
- NDC Code(s): 64778-0378-1
- Packager: AMD Medicom Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated January 3, 2019
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AMD Medicom Inc.
2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)
4.4 oz / 125 g
Rx Only in US
Item code 10037-RBClose
- 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
Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
- INACTIVE INGREDIENT
Water, sucralose, sodium phosphate, xylitol, betaine, pluronic, raspberry flavorClose
- WARNINGS AND PRECAUTIONS
Warnings: KEEP OUT OF REACH OF CHILDREN
Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.
Do not use if seal is broken.
Rx (in US only)Close
- SPL UNCLASSIFIED SECTION
Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebec, Canada
- INGREDIENTS AND APPEARANCE
DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE RASPBERRY
sodium fluoride aerosol, foam
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0378 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 RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64778-0378-1 125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2005 12/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2005 12/31/2020 Labeler - AMD Medicom Inc (256880576) Registrant - AMD Medicom Inc. (256880576)