FDA.reportPublic FDA data

iBrite

Manufacturer
Pac-Dent International Inc.
Effective date
2015-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:48

Label at a glance#

ProductiBrite
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient listActive ingredient list

INACTIVE INGREDIENT SECTION

Inactive ingredients listInactive ingredients list

WARNINGS SECTION

WarningsWarnings

DOSAGE & ADMINISTRATION SECTION

DosageDosage

INDICATIONS & USAGE SECTION

DirectionDirection

OTC - PURPOSE SECTION

OTC-purposeOTC-purpose

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal display panelPrincipal display panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68983-006-022020-01-31C16284748780-19d75b9d1-03f9-f424-e053-dadaa90a57ce25f0e453-ed76-141b-e054-00144ff8d46c
68983-006-042020-01-31C16284748780-19d75b9d1-03f9-f424-e053-dadaa90a57ce25f0e453-ed76-141b-e054-00144ff8d46c

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68983-00668983-006-01, 68983-006-02, 68983-006-03, 68983-006-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
GLYCERINPDC6A3C0OXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
HYDRATED SILICAY6O7T4G8P9IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM PHOSPHATE, TRIBASICA752Q30A6XIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT

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
25f0e453-ed77-141b-e054-00144ff8d46c25f0e453-ed76-141b-e054-00144ff8d46c2015-12-02WarningsExact identifier
spl id: 25f0e453-ed77-141b-e054-00144ff8d46c
spl set id: 25f0e453-ed76-141b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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