Colgate MaxFresh with Mini Breath Clean Mint

Manufacturer: Colgate-Palmolive Company
Effective date: 2024-11-14
Label type: HUMAN OTC DRUG LABEL
Version: 18
Source: full-release
Hydrated at: 2026-06-01 01:37:45

Label at a glance#

ProductColgate MaxFresh with Mini Breath 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

Contacts and useful links#

PhoneLabel contact1-800-468-6502

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 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide, Yellow 5.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate^®
Anticavity Fluoride Toothpaste

10X
LONGER
LASTING
COOL^†

Max Fresh_®
WITH WHITENING

BREATH STRIPS

Recyclable
Tube

NET WT 6.0 OZ (170 g)

CLEAN MINT

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
416783	sodium fluoride 0.24 % Toothpaste	PSN	18
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	18
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	18
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	18
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-013-30	Colgate MaxFresh with Mini Breath Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	18
35000-013-30	Colgate MaxFresh with Mini Breath Clean Mint	3 in 1 CELLO PACK	PASTE, DENTIFRICE	3	18
35000-013-34	Colgate MaxFresh with Mini Breath Clean Mint	170 g in 1 TUBE	PASTE, DENTIFRICE	170	18
35000-013-34	Colgate MaxFresh with Mini Breath Clean Mint	2 in 1 CARTON	PASTE, DENTIFRICE	2	18
35000-013-60	Colgate MaxFresh with Mini Breath Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	18
35000-013-60	Colgate MaxFresh with Mini Breath Clean Mint	170 g in 1 TUBE	PASTE, DENTIFRICE	170	18
35000-013-74	Colgate MaxFresh with Mini Breath Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	18
35000-013-74	Colgate MaxFresh with Mini Breath Clean Mint	182 g in 1 TUBE	PASTE, DENTIFRICE	182	18
35000-013-78	Colgate MaxFresh with Mini Breath Clean Mint	221 g in 1 TUBE	PASTE, DENTIFRICE	221	18
35000-013-78	Colgate MaxFresh with Mini Breath Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	18
35000-013-95	Colgate MaxFresh with Mini Breath Clean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	18
35000-013-95	Colgate MaxFresh with Mini Breath Clean Mint	178 g in 1 TUBE	PASTE, DENTIFRICE	178	18
35000-013-97	Colgate MaxFresh with Mini Breath Clean Mint	2 in 1 CARTON	PASTE, DENTIFRICE	2	18
35000-013-97	Colgate MaxFresh with Mini Breath Clean Mint	178 g in 1 TUBE	PASTE, DENTIFRICE	178	18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	1
Cocamidopropyl Betaine	INACTIVE INGREDIENT	5OCF3O11KX	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	1
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	1
Methylcellulose (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	1
Polyethylene Glycol 600	INACTIVE INGREDIENT	NL4J9F21N9	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sodium Pyrophosphate	INACTIVE INGREDIENT	O352864B8Z	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Colgate MaxFresh with Mini Breath Clean Mint
SODIUM FLUORIDE
FLUORIDE ION
SORBITOL
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SODIUM PYROPHOSPHATE
COCAMIDOPROPYL BETAINE
SACCHARIN SODIUM
HYPROMELLOSE, UNSPECIFIED
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
35000-013	35000-013-34, 35000-013-60, 35000-013-78, 35000-013-74, 35000-013-95, 35000-013-97, 35000-013-30

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
POLYETHYLENE GLYCOL 600	NL4J9F21N9	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
SODIUM PYROPHOSPHATE	O352864B8Z	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 312 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, EXTENDED RELEASE / ORAL	2.5 mg		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE / ORAL	652 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / BUCCAL	0.11 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / ORAL	180 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, EXTENDED RELEASE / ORAL	2.03 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, EXTENDED RELEASE / ORAL	2.5 mg		Exact identifier — unii candidate 72 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET / ORAL	6 mg		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, FILM COATED / ORAL	1.68 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE / ORAL		1742 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE / ORAL	652 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, CHEWABLE / ORAL	4.5 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / ORAL	180 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / SUBLINGUAL	0.11 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / SUBLINGUAL	0.11 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE / ORAL		1742 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE, LIQUID FILLED / ORAL		1584 mg	Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / BUCCAL	0.11 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	ELIXIR / ORAL	0.15 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 176 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, EXTENDED RELEASE / ORAL	2.03 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, COATED / ORAL	7.93 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Sodium Pyrophosphate	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w		Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE / ORAL	652 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, EXTENDED RELEASE / ORAL	2.5 mg		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION, SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / ORAL	180 mg		Exact identifier — unii candidate 176 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	SOLUTION / ORAL	650 mg/5ml		Exact identifier — unii candidate 72 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 176 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route+dosage form 8 equally ranked IID candidates
Polyethylene Glycol 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET / ORAL	6 mg		Exact identifier — unii candidate 72 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate MaxFresh with Mini Breath Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	82bc1101-84d7-4e21-be9c-870ad88a4b7c	2024-11-14	Warnings	Exact identifier ndc (package): 35000-013-60 ndc (package): 35000-013-78 ndc (package): 35000-013-97 ndc (package): 35000-013-95 ndc (package): 35000-013-30 ndc (package): 35000-013-74 ndc (package): 35000-013-34 ndc (product): 35000-013 ndc11 (package): 35000001360 ndc11 (package): 35000001378 ndc11 (package): 35000001334 ndc11 (package): 35000001330 ndc11 (package): 35000001395 ndc11 (package): 35000001397 ndc11 (package): 35000001374 spl id: e6c8cb12-5fdc-4a5d-855e-e68e1f156b17 spl set id: 82bc1101-84d7-4e21-be9c-870ad88a4b7c

Reported adverse events (FAERS/openFDA)#

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