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  5. Label Information: Denti-care Topical Fluoride Foam Bubble Gum

FDA Label for Denti-care Topical Fluoride Foam Bubble Gum

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. DOSAGE & ADMINISTRATION
    3. INACTIVE INGREDIENT
    4. WARNINGS AND PRECAUTIONS
    5. OTHER
    6. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Denti-care Topical Fluoride Foam Bubble Gum Product Label

The following document was submitted to the FDA by the labeler of this product Ar Medicom Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



Denti-Care

Denti-Foam

Topical Fluoride Foam Bubble Gum

1.23 % Fluoride Ions

4.4 oz / 125 g

NDC 64778-1373-1



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



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

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 Only

Other



Manufactured in Canada forAR Medicom Inc Montreal, Canada, H8T 3J8Questions 1-800-361-2862 or www.medicom.comUPC 686864008668Item code 10037-BGRev 00

Package Label.Principal Display Panel



10037foambg - 10037foambg

10037foambg - 10037foambg


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