PCxx

PCXX — sodium fluoride aerosol, foam
Ross Healthcare Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 27121A6EXPIRY 12-2014

Ross Healthcare PCxx Label
(click image for full-size original)
PCXX sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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) SODIUM FLUORIDE 2.5 g in 125 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
XYLITOL
SUCRALOSE
POLOXAMER 407
SODIUM LAURYL SULFATE
XANTHAN GUM
POTASSIUM SORBATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62007-105-07 125 g in 1 CANISTER None
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 Operations
Ross Healthcare Inc. 244249012 manufacture (62007-105)

Revised: 12/2012 Ross Healthcare Inc.

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