PCXX BUBBLEGUM NEUTRAL 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 21:24:39

Label at a glance#

ProductPCXX BUGGLEGUM NEUTRAL GL
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245593sodium fluoride 2 % Dental GelPSN6
245593sodium fluoride 0.02 MG/MG Oral GelSCD6
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY6
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-126-162021-01-31C16284748780-1ba0f9c33-1a5d-a910-e053-dadaa90a0b85PCXX BUBBLEGUM NEUTRAL GEL
62007-126-162021-01-29C16284748780-1ba0f9c33-1a5d-a910-e053-dadaa90a0b85PCXX BUBBLEGUM NEUTRAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-126-16PCXX BUGGLEGUM NEUTRAL GL473 g in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-126PCXX BUGGLEGUM NEUTRAL GL (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]6Legacy NDC, 1 package rows20250201_5e39590d-c15b-e645-e053-2a91aa0afd27.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
62007-12662007-126-16

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
2cf68321-07c4-61be-e063-6294a90adde75e39590d-c15b-e645-e053-2a91aa0afd272025-01-30Exact identifier
spl id: 2cf68321-07c4-61be-e063-6294a90adde7
spl set id: 5e39590d-c15b-e645-e053-2a91aa0afd27

Reported adverse events (FAERS/openFDA)#

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