FDA.reportPublic FDA data

Colgate Optic White Renewal High Impact White

Manufacturer
Colgate-Palmolive Company
Effective date
2019-10-30
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:39:43

Label at a glance#

ProductColgate Optic White Renewal High Impact White
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, Hydrogen Peroxide, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Silica, Sucralose, BHT.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

NEW

OPTIC
WHITE®

RENEWAL

REMOVES
10 YEARS OF
YELLOW STAINS*

HYDROGEN
3%
PEROXIDE

HIGH IMPACT WHITE

NET WT 3.0 OZ (85 g)

ENAMEL SAFE

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN8
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD8
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY8
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY8
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY8
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY8

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-982-15Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-15Colgate Optic White Renewal High Impact White20 g in 1 TUBEPASTE, DENTIFRICE208
35000-982-41Colgate Optic White Renewal High Impact White116 g in 1 TUBEPASTE, DENTIFRICE1168
35000-982-41Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-43Colgate Optic White Renewal High Impact White121 g in 1 TUBEPASTE, DENTIFRICE1218
35000-982-43Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-62Colgate Optic White Renewal High Impact White85 g in 1 TUBEPASTE, DENTIFRICE858
35000-982-62Colgate Optic White Renewal High Impact White2 in 1 CARTONPASTE, DENTIFRICE28
35000-982-63Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-63Colgate Optic White Renewal High Impact White85 g in 1 TUBEPASTE, DENTIFRICE858

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
35000-98235000-982-63, 35000-982-62, 35000-982-15, 35000-982-41, 35000-982-43

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
PROPYLENE GLYCOL6DC9Q167V3IACT
CALCIUM PYROPHOSPHATEX69NU20D19IACT
POVIDONE K15E54VE15114IACT
PEG/PPG-116/66 COPOLYMERJP0CK963E0IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72019-10-30full-release2026-06-01 00:40:19

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
5f8d57ef-2ba3-45a4-a783-e65dff284cc90b90a131-7933-4501-a174-e35aa95b56c32019-10-30WarningsExact identifier
spl id: 5f8d57ef-2ba3-45a4-a783-e65dff284cc9
spl set id: 0b90a131-7933-4501-a174-e35aa95b56c3

Reported adverse events (FAERS/openFDA)#

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