Colgate

Manufacturer
Colgate-Palmolive Company | Mission Hills, S.A. de C.V.
Effective date
2026-07-22
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-07-25 05:10:08

Label at a glance#

ProductColgate Max Fresh Cool 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% (0.14% 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

Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Glycerin, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

DIST. BY:
COLGATE-PALMOLIVE COMPANY,
NEW YORK, NY 10022 USA

PRINCIPAL DISPLAY PANEL - 178 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity
Fluoride Toothpaste

Cool Mint
WITH BREATH STRIPS

NET WT 6.3 OZ (178 g)

MaxFresh®

FRESHNESS POWERED BY
ULTRAFREEZE
10X LONGER LASTING COOL FOR FRESH BREATH†

PRINCIPAL DISPLAY PANEL - 178 g Tube Carton
PRINCIPAL DISPLAY PANEL - 178 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-90335000-903-60, 35000-903-01, 35000-903-75, 35000-903-78, 35000-903-99, 35000-903-58, 35000-903-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62019-11-27full-release2026-06-01 01:39:39
42019-11-27full-release2026-06-01 00:38:59

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 Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
ndc (package): 35000-903-78
ndc (package): 35000-903-95
ndc (package): 35000-903-99
ndc (package): 35000-903-01
ndc (package): 35000-903-60
ndc (package): 35000-903-75
ndc (package): 35000-903-58
ndc (product): 35000-903
ndc11 (package): 35000090301
ndc11 (package): 35000090378
ndc11 (package): 35000090360
ndc11 (package): 35000090395
ndc11 (package): 35000090399
ndc11 (package): 35000090358
ndc11 (package): 35000090375
spl id: 14f9feea-6d53-476e-84c5-4a6cabd5c0ac
spl set id: 00652bb2-090c-4eaa-8fc2-e0be6913a724