Colgate

Manufacturer
Colgate-Palmolive Company | Mission Hills, S.A. de C.V.
Effective date
2026-09-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-09-09 00:01:25

Label at a glance#

ProductColgate Optic White Advanced Sparkling White
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#

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, Phosphoric Acid, BHT, Water.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

PRINCIPAL DISPLAY PANEL - 127 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

NOW 2X WHITENING INGREDIENT†

OPTIC
WHITE®

ADVANCED

ENAMEL SAFE
NET WT 4.5 OZ (127 g)

SPARKLING WHITE®

DEEPLY WHITENS FOR
UP TO FOUR SHADES*

HYDROGEN
2%
PEROXIDE

PRINCIPAL DISPLAY PANEL - 127 g Tube Carton
PRINCIPAL DISPLAY PANEL - 127 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-06-26monthly-update2026-07-17 21:37:01
42019-10-10full-release2026-06-01 01:34:21

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
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
ndc (package): 35000-978-86
ndc (package): 35000-978-44
ndc (package): 35000-978-71
ndc (package): 35000-978-25
ndc (package): 35000-978-14
ndc (package): 35000-978-76
ndc (package): 35000-978-32
ndc (package): 35000-978-16
ndc (product): 35000-978
ndc11 (package): 35000097816
ndc11 (package): 35000097844
ndc11 (package): 35000097832
ndc11 (package): 35000097825
ndc11 (package): 35000097814
ndc11 (package): 35000097886
ndc11 (package): 35000097871
ndc11 (package): 35000097876
spl id: ab74961c-dfbd-4213-bb8f-f65cf6be852a
spl set id: bc56603d-4190-48c1-b16e-3179a650cb39

Reported adverse events (FAERS/openFDA)#

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