PCXX VANILLA ORANGE NEUTRAL F- sodium fluoride aerosol, foam

PCXX VANILLA ORANGE NEUTRAL F by

Drug Labeling and Warnings

PCXX VANILLA ORANGE NEUTRAL F by is a Prescription medication manufactured, distributed, or labeled by Ross Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minute

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PCXX VANILLA ORANGE NEUTRAL F 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62007-101
Route of Administration	TOPICAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62007-101-07	125 g in 1 CAN; Type 0: Not a Combination Product	11/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/21/2017

Labeler - Ross Healthcare Inc. (064974821)