COLGATE OPTIC WHITE PRO SERIES

Manufacturer
Mission Hills, S.A. de C.V.
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:28:27

Label at a glance#

ProductCOLGATE OPTIC WHITE PRO SERIES
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Dosage and administration

adults and children 6 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 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 6 years do not use unless directed by a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 1.14% (0.18% 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 Contol Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 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 6 to 12 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 6 yearsdo not use unless directed by 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, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Flavor, 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

2
VALUE
PACK

OPTIC
WHITE®

PRO SERIES

REMOVES
15 YEARS
OF DEEP-SET STAINS*

ACTIVSHINE
TECHNOLOGY

5%
HYDROGEN
PEROXIDE

ENAMEL RENEWAL

PASTE
SOOTHING MINT

TWO 3.0 OZ (85 g) TUBES • TOTAL NET WT 6.0 OZ (170 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
1038995sodium monofluorophosphate 1.14 % ToothpastePSN1
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD1
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY1
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY1
1038995sodium monofluorophosphate 1.14 % ToothpasteSY1

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
65954-845-62COLGATE OPTIC WHITE PRO SERIES2 in 1 CARTONPASTE, DENTIFRICE21
65954-845-62COLGATE OPTIC WHITE PRO SERIES85 g in 1 TUBEPASTE, DENTIFRICE851
65954-845-63COLGATE OPTIC WHITE PRO SERIES85 g in 1 TUBEPASTE, DENTIFRICE851
65954-845-63COLGATE OPTIC WHITE PRO SERIES1 in 1 CARTONPASTE, DENTIFRICE11

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
65954-84565954-845-63, 65954-845-62

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
fad24e59-3511-4b57-a986-11c1409e25a8a48e83ae-a02a-4a6d-a601-7acaba3bbbc92025-12-23WarningsExact identifier
spl id: fad24e59-3511-4b57-a986-11c1409e25a8
spl set id: a48e83ae-a02a-4a6d-a601-7acaba3bbbc9

Reported adverse events (FAERS/openFDA)#

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