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PCXX Foam

Generic Name: sodium fluoride
Dosage Form: aerosol, foam

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

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 
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) 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
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 Operations
Ross Healthcare Inc. 244249012 manufacture(62007-105)
Revised: 12/2012
 
Ross Healthcare Inc.



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