OPTIC WHITE PRO SERIES VIBRANT CLEAN

Manufacturer
Mission Hills, S.A. de C.V.
Effective date
2025-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:39:39

Label at a glance#

ProductOPTIC WHITE PRO SERIES VIBRANT CLEAN
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, PEG/PPG-116/66 Copolymer, Water, Hydrogen Peroxide (5% w/v), PVP, Silica, Flavor, Sodium Lauryl Sulfate, 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 U.S.A.

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®
PRO SERIES

REMOVES
15 YEARS
OF DEEP-SET STAINS*

ACTIVSHINE
TECHNOLOGY

5%
HYDROGEN
PEROXIDE

VIBRANT CLEAN

PASTE FRESH MINT

ENAMEL SAFE

NET WT 3.0 OZ (85 g)

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-838-63OPTIC WHITE PRO SERIES VIBRANT CLEAN1 in 1 CARTONPASTE, DENTIFRICE11
65954-838-63OPTIC WHITE PRO SERIES VIBRANT CLEAN85 g in 1 TUBEPASTE, DENTIFRICE851

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65954-83865954-838-63

Ingredients#

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

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

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
d00208f1-3255-405f-a081-89966866324eecebd253-e134-4c1e-b105-d53dcc7e0d792026-08-06WarningsExact identifier
spl set id: ecebd253-e134-4c1e-b105-d53dcc7e0d79

Reported adverse events (FAERS/openFDA)#

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