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PCXX CREME DE MENTHE APF G

PCXX CREME DE MENTHE APF GEL

Approved
Approval ID

8281bc97-3816-8653-e053-2991aa0a0f50

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2024

Manufacturers
FDA

Ross Healthcare Inc.

DUNS: 064974821

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride

PRODUCT DETAILS

NDC Product Code62007-806
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL, DENTAL
Effective DateJanuary 31, 2024
Generic NameSodium Fluoride

INGREDIENTS (1)

SODIUM FLUORIDEActive
Quantity: 27.2 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/17/2017

principal display panel

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/20/2017

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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