FDA.reportPublic FDA data

Colgate Optic White Platinum Express White Fresh Mint

Manufacturer
Team Technologies, Inc
Effective date
2016-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:02

Label at a glance#

ProductColgate Optic White Platinum Express White Fresh Mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Dosage and administration

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.12% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

propylene glycol, calcium pyrophosphate, PVP, PEG/PPG-116/66 copolymer, PEG-12, glycerin, flavor, hydrogen peroxide, sodium lauryl sulfate, silica, tetrasodium pyrophosphate, sodium saccharin, disodium pyrophosphate, sucralose, BHT

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

Colgate ®

OPTIC
WHITE ®
PLATINUM
ANTICAVITY FLUORIDE TOOTHPASTE

EXPRESS
WHITE

WHITER TEETH IN
3 DAYS

2X WHITENING INGREDIENT*

ENAMEL SAFE

FRESH MINT

NET WT 0.75 OZ (21 g)

PRINCIPAL DISPLAY PANEL - 20 g Tube Carton
PRINCIPAL DISPLAY PANEL - 20 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130035000767097GTIN-13: 0035000767097
EAN-13: 0035000767097
GTIN-12: 035000767097
UPC-A: 035000767097
GTIN storage (14 digits): 00035000767097		colgate-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67659-340-032020-01-31C16284748780-19d75b9d0-c50b-f424-e053-dadaa90a57ceColgate ® Optic White ® Platinum Express White Fresh Mint Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67659-340-03Colgate Optic White Platinum Express White Fresh Mint127 g in 1 TUBEPASTE, DENTIFRICE1271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67659-340COLGATE OPTIC WHITE PLATINUM EXPRESS WHITE FRESH MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TEAM TECHNOLOGIES, INC]1Legacy NDC, 1 package rows20160520_3349e22c-d3da-66d5-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67659-34067659-340-03
65954-774

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
CALCIUM PYROPHOSPHATEX69NU20D19IACT
POVIDONESFZ989GH94EIACT
PEG/PPG-116/66 COPOLYMERJP0CK963E0IACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SUCRALOSE96K6UQ3ZD4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

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
3349e22c-d3db-66d5-e054-00144ff8d46c3349e22c-d3da-66d5-e054-00144ff8d46c2016-05-20WarningsExact identifier
spl id: 3349e22c-d3db-66d5-e054-00144ff8d46c
spl set id: 3349e22c-d3da-66d5-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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