Active Ingredient
ACTIVE INGREDIENT: 2.0% Sodium Fluoride
Pcxx
FDA Label NDC 62007-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ross Healthcare Inc. for the product Pcxx (NDC 62007-105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, use, keep out of reach of children, cautions and warnings, directions for use, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Ross Healthcare Pcxx Label (Ross Hc Pcxx)
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