Denti-Care Denti-Foam Topical Sodium Fluoride Foam

Generic Name: fluoride ions

Dosage Form: aerosol, foam
Denti-Care Denti-Foam Topical Fluoride Foam Orange 1.23% Fluoride Ions

Denti-Care

Denti-Foam

Topical Fluoride Foam Orange

1.23 % Fluoride Ions

4.4 oz / 125 g

NDC 64778-1377-1

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)

Non-Medicinal ingredients: sodium saccharin, sodium benzoate, plasdone C30, glycerin USP, propylene glycol, polysorbate 20, stepanol WA 100, phosphoric acid, purified water, orange flavor

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 Only
Manufactured in Canada for

AR Medicom Inc

Montreal, Canada, H8T 3J8

Questions 1-800-361-2862 or www.medicom.com

UPC 686864008651

Item code 10037-O

Rev 00

DENTI-CARE  TOPICAL FLUORIDE FOAM ORANGE fluoride ions  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64778-1377 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (FLUORIDE ION) sodium fluoride .0176 g  in 1 g HYDROFLUORIC ACID (FLUORIDE ION) HYDROFLUORIC ACID 0.010 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor ORANGE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64778-1377-1 125 g In 1 BOTTLE, SPRAY None

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)

Revised: 02/2011AR Medicom Inc

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