PCXX HOMEGEL NF G- sodium fluoride gel

PCXX HOMEGEL NF G by

Drug Labeling and Warnings

PCXX HOMEGEL NF G 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 HOMEGEL NF G 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62007-135
Route of Administration	DENTAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	11.1 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62007-135-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/28/2019

Labeler - Ross Healthcare Inc. (064974821)