FDA Label for Pcxx
View Indications, Usage & Precautions
Pcxx Product Label
The following document was submitted to the FDA by the labeler of this product Ross Healthcare Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
ACTIVE INGREDIENT: 2.0% Sodium Fluoride
Use
Use: Professional Use Anticavity Treatment
Use: Professional Use Anticavity Treatment
Keep Out Of Reach Of Children
Keep out of reach of children.
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
* Please review the disclaimer below.