COLGATE OPTIC WHITE PURPLE

Manufacturer
Mission Hills, S.A. de C.V.
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:39:39

Label at a glance#

ProductCOLGATE OPTIC WHITE PURPLE
Active ingredientSODIUM FLUORIDE
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 Fluoride 0.24% (0.15% 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

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Blue 1, Red 33, Titanium Dioxide.

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 - 107 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®
PURPLE

PASTE FRESH MINT

REMOVES 1 YEAR
OF STAINS*
WITH MICRO-POLISHING ACTION

NET WT 3.8 OZ (107 g)

ENAMEL SAFE

Principal Display Panel - 107 g Tube Carton
Principal Display Panel - 107 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-837-59COLGATE OPTIC WHITE PURPLE1 in 1 CARTONPASTE, DENTIFRICE11
65954-837-59COLGATE OPTIC WHITE PURPLE107 g in 1 TUBEPASTE, DENTIFRICE1071

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65954-83765954-837-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
00ac7cb9-5ce0-40bf-98cf-dfd190537efff83032bf-7ee8-4836-bd70-f7eaeab892cd2025-10-15WarningsExact identifier
spl id: 00ac7cb9-5ce0-40bf-98cf-dfd190537eff
spl set id: f83032bf-7ee8-4836-bd70-f7eaeab892cd

Reported adverse events (FAERS/openFDA)#

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