PCXX- sodium fluoride aerosol, foam

PCxx by

Drug Labeling and Warnings

PCxx by is a Prescription medication manufactured, distributed, or labeled by Ross Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

PCXX 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62007-105
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.5 g  in 125 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/12/2012

Labeler - Ross Healthcare Inc. (244249012)

Registrant - Ross Healthcare Inc. (244249012)

Establishment
Name	Address	ID/FEI	Business Operations
Ross Healthcare Inc.		244249012	manufacture(62007-105)