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PCxx

Ross Healthcare Inc.
Ross Healthcare Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

ACTIVE INGREDIENT: 2.0% Sodium Fluoride

Use

Use: Professional Use Anticavity Treatment

Keep Out Of Reach Of Children

Keep out of reach of children.

Use

Use: Professional Use Anticavity Treatment

Cautions and Warnings

Cautions and Warnings:

Keep out of reach of children. Rx only. Do not puncture or incinerate. Do not store above 50 degrees C. Do not use in the presence of open flame. Contents under pressure. Do not place near any heat source.

Directions For Use

DIRECTIONS FOR USE:

1. Use after prophylaxis.

2. Shake bottle vigorously for 3-4 seconds.

3. For adults and children age 6 and older.

4. Invert applicator.

5. Place nozzle to applicator tray and dispense.

6. Allow foam to expand in tray.

7. Have patient bite down for up to 4 minutes.

8. Remove trays and have patient expectorate excess.

9. Do not eat or drink for 30 minutes after use.

Inactive Ingredients

INACTIVE INGREDIENTS: Glycerin, Xylitol, Sucralose, Poloxamer, Sodium Lauryl Sulphate, Xantham Gum, Flavour, Potassium Sorbate.

Product Label

PCxx

Professional Care Products

NEUTRAL FOAM

TOPICAL FLUORIDE FOAM

2.0% Sodium Fluoride

NO FLAVOR

Net Contents: 125 g

NPN# 800004635

NDC# 062007-105-07

Ross Healthcare Inc.  1-800-663-8303 / www.rosshealthcare.org

Made in Canada

LOT 27121A6

EXPIRY 12-2014

PCxx

PCxx

SODIUM FLUORIDE AEROSOL, FOAM

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:62007-105
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 2.5 g

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
Xylitol
Sucralose
POLOXAMER 407
SODIUM LAURYL SULFATE
XANTHAN GUM
POTASSIUM SORBATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62007-105-07 125 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-12-12


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