PCXX RASPBERRY APF GEL

Manufacturer
Ross Healthcare Inc.
Effective date
2025-01-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 21:24:41

Label at a glance#

ProductPCXX RASPBERRY APF G
Active ingredientSODIUM FLUORIDE
Label structure2 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panelprincipal display panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-809-162021-01-31C16284748780-1ba0f9c33-1ae7-a910-e053-dadaa90a0b85PCXX RASPBERRY APF GEL
62007-809-162021-01-29C16284748780-1ba0f9c33-1ae7-a910-e053-dadaa90a0b85PCXX RASPBERRY APF GEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-809PCXX RASPBERRY APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]6Legacy NDC20250201_8281515f-08ab-509c-e053-2a91aa0abae3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62007-80962007-809-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3b5b93f2-b426-32b2-e063-6394a90ae8878281515f-08ab-509c-e053-2a91aa0abae32025-08-02Exact identifier
spl set id: 8281515f-08ab-509c-e053-2a91aa0abae3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.