PCXX CREME DE MENTHE APF G: Package Insert and Label Information

PCXX CREME DE MENTHE APF G- sodium fluoride gel
Ross Healthcare Inc.

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.

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

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PCXX CREME DE MENTHE APF G
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62007-806
Route of Administration TOPICAL, DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 27.2 mg in 1 mL
Product Characteristics
Color green Score
Shape Size
Flavor MINT, MARSHMALLOW Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62007-806-16 473 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/04/2019
Labeler — Ross Healthcare Inc. (064974821)

Revised: 01/2021 Ross Healthcare Inc.

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