DENTI-CARE TOPICAL FLUORIDE FOAM BUBBLE GUM- fluoride ions aerosol, foam

Denti-Care by

Drug Labeling and Warnings

Denti-Care by is a Prescription medication manufactured, distributed, or labeled by AR Medicom Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

Manufactured in Canada for
AR Medicom Inc
Montreal, Canada, H8T 3J8
Questions 1-800-361-2862 or www.medicom.com
UPC 686864008668
Item code 10037-BG
Rev 00

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTI-CARE  TOPICAL FLUORIDE FOAM BUBBLE GUM
fluoride ions aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-1373
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	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-1373-1	125 g in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/09/2011

Labeler - AR Medicom Inc (247876295)