FDA.reportPublic FDA data

Colgate Optic White Pro Series Stain Prevention

Manufacturer
Colgate-Palmolive Company | Mission Hills, S.A. de C.V.
Effective date
2019-10-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:40:41

Label at a glance#

ProductColgate Optic White Pro Series Stain Prevention
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 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#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% (0.13% 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 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 59 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®

PRO SERIES

REMOVES
15 YEARS
OF STAINS*

5%
HYDROGEN
PEROXIDE

STAIN PREVENTION

NET WT 2.1 OZ (59 g)

PRINCIPAL DISPLAY PANEL - 59 g Tube Label
PRINCIPAL DISPLAY PANEL - 59 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-747-16Colgate Optic White Pro Series Stain Prevention6 g in 1 TUBEPASTE, DENTIFRICE65
35000-747-16Colgate Optic White Pro Series Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE15
35000-747-21Colgate Optic White Pro Series Stain Prevention59 g in 1 TUBEPASTE, DENTIFRICE595
35000-747-21Colgate Optic White Pro Series Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE15
35000-747-30Colgate Optic White Pro Series Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE15
35000-747-30Colgate Optic White Pro Series Stain Prevention85 g in 1 TUBEPASTE, DENTIFRICE855
35000-747-32Colgate Optic White Pro Series Stain Prevention93 g in 1 TUBEPASTE, DENTIFRICE935
35000-747-32Colgate Optic White Pro Series Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE15

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-74735000-747-30, 35000-747-32, 35000-747-21, 35000-747-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
POLOXAMER 105XPP85ZHV76IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
CALCIUM PYROPHOSPHATEX69NU20D19IACT
PEG/PPG-116/66 COPOLYMERJP0CK963E0IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SUCRALOSE96K6UQ3ZD4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42019-10-31full-release2026-06-01 00:39:29

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
d3bb082f-406f-4282-8576-720e81042c30e18060c0-7e03-444c-a5ac-b8ba25ce14ea2026-07-07WarningsExact identifier
spl set id: e18060c0-7e03-444c-a5ac-b8ba25ce14ea

Reported adverse events (FAERS/openFDA)#

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