Colgate

Manufacturer
Mission Hills S.A de C.V
Effective date
2026-09-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-22 03:02:55

Label at a glance#

ProductColgate Optic White Stain Fighter Clean Mint
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, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, cocamidopropyl betaine, sodium saccharin, xanthan gum, sodium hydroxide, 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 - 119 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
STAIN REMOVAL
TECHNOLOGY**

Colgate®

OPTIC
WHITE®

STAIN FIGHTER™

REMOVES 6X MORE SURFACE STAINS*
WITH MICRO-POLISHING ACTION

NET WT 4.2 OZ (119 g)
ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE WHITENING

CLEAN MINT PASTE

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130035000458360GTIN-13: 0035000458360
EAN-13: 0035000458360
GTIN-12: 035000458360
UPC-A: 035000458360
GTIN storage (14 digits): 00035000458360
colgate-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

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
65954-40365954-403-71, 65954-403-02, 65954-403-60, 65954-403-33, 65954-403-30

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72018-12-18full-release2026-06-01 00:39:03

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
3ec5c026-18dd-447f-8e9a-8a5484f356331726a2d2-8580-4059-81ec-bbfb3af794922018-12-18WarningsExact identifier
spl set id: 1726a2d2-8580-4059-81ec-bbfb3af79492

Reported adverse events (FAERS/openFDA)#

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