Label: DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE ORANGE- sodium fluoride aerosol, foam
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- NDC Code(s): 64778-0377-1
- Packager: AR Medicom Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated February 25, 2010
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- DESCRIPTION
Medicom
Denti-Care
Denti-Foam
2.72 % Topical Sodium Fluoride Foam (1.23 % Fluoride Ions)
Orange
4.4 oz / 125 g
NDC 64778-0377-1
NPN 80009738
Close - 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 2.72 % w/w sodium fluoride)
Close - INACTIVE INGREDIENT
Non-Medicinal ingredients: cocamidopropyl betaine, phosphoric acid, poloxamer 407, sucralose, tartaric acid, xylitol, purified water, orange flavour
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- 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)
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- SPL UNCLASSIFIED SECTION
Manufactured in USA for AR Medicom Inc., Montreal, Canada, H8T 3J8
Questions 1-800-361-2862 or www.medicom.com
UPC 686864008651
No. 112480
Item Code 10037-O
Rev 2 Close - INGREDIENTS AND APPEARANCE
DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE ORANGE
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0377 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion .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:64778-0377-1 125 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 CloseLabeler - AR Medicom Inc (247876295)
