Colgate

Manufacturer: Mission Hills S.A de C.V | Colgate-Palmolive Company
Effective date: 2019-04-09
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: full-release
Hydrated at: 2026-06-01 00:39:28

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

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, methylcellulose, FD&C blue no. 1

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate^®
Anticavity
Fluoride Toothpaste

NET WT 6.0 OZ (170 g)

COOL MINT

Max Fresh^®
with WHITENING

BREATH STRIPS

FRESHNESS THAT LASTS FOR HOURS!

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	16
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	16
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	16
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	16
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65954-014-01	ColgateMax Fresh Cool Mint	28.3 g in 1 TUBE	GEL, DENTIFRICE	28.3	16
65954-014-01	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-58	ColgateMax Fresh Cool Mint	70 g in 1 TUBE	GEL, DENTIFRICE	70	16
65954-014-58	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-60	ColgateMax Fresh Cool Mint	170 g in 1 TUBE	GEL, DENTIFRICE	170	16
65954-014-60	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-63	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-63	ColgateMax Fresh Cool Mint	178 g in 1 TUBE	GEL, DENTIFRICE	178	16
65954-014-75	ColgateMax Fresh Cool Mint	79 g in 1 TUBE	GEL, DENTIFRICE	79	16
65954-014-75	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-78	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-78	ColgateMax Fresh Cool Mint	221 g in 1 TUBE	GEL, DENTIFRICE	221	16
65954-014-95	ColgateMax Fresh Cool Mint	178 g in 1 TUBE	GEL, DENTIFRICE	178	16
65954-014-95	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-99	ColgateMax Fresh Cool Mint	1 in 1 CARTON	GEL, DENTIFRICE	1	16
65954-014-99	ColgateMax Fresh Cool Mint	53 g in 1 TUBE	GEL, DENTIFRICE	53	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65954-014	COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]	16	Current NDC, Legacy NDC, 16 package rows	20241127_d142e43f-415a-41c5-a7db-8b18a039a323.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	6
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	6
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	6
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	6
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	6
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	6
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	6
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	6
SODIUM PYROPHOSPHATE	INACTIVE INGREDIENT	O352864B8Z	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Colgate Max Fresh Cool Mint
SODIUM FLUORIDE
FLUORIDE ION
SORBITOL
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SODIUM PYROPHOSPHATE
COCAMIDOPROPYL BETAINE
SACCHARIN SODIUM
POWDERED CELLULOSE
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65954-014	65954-014-60, 65954-014-01, 65954-014-75, 65954-014-78, 65954-014-99, 65954-014-58, 65954-014-63, 65954-014-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
POWDERED CELLULOSE	SMD1X3XO9M	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML

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 5 · 243 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, EXTENDED RELEASE / ORAL	2.5 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE / ORAL		1742 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE / ORAL		1742 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE / DENTAL		249 mg	Exact identifier — unii+route 27 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION, SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM PYROPHOSPHATE	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PYROPHOSPHATE	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	SOLUTION / ORAL	650 mg/5ml		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET / ORAL	6 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii+route 45 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE / DENTAL		249 mg	Exact identifier — unii+route 27 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE, LIQUID FILLED / ORAL		1584 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET / ORAL	6 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route 9 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION, SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM PYROPHOSPHATE	SODIUM PYROPHOSPHATE	O352864B8Z	PASTE, DENTIFRICE / DENTAL	1 %w/w		Exact identifier — unii+route 9 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii+route 45 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, EXTENDED RELEASE / ORAL	2.5 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	CAPSULE, LIQUID FILLED / ORAL		1584 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii+route 45 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	TABLET, DELAYED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GEL / DENTAL	0.4 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii+route 18 equally ranked IID candidates
POLYETHYLENE GLYCOL 600	POLYETHYLENE GLYCOL 600	NL4J9F21N9	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE / DENTAL		249 mg	Exact identifier — unii+route 27 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route 27 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE, DENTIFRICE / DENTAL	1.2 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii+route 27 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 Max Fresh Cool Mint	SODIUM FLUORIDE	Mission Hills S.A de C.V	d142e43f-415a-41c5-a7db-8b18a039a323	2019-04-09	Warnings	Exact identifier ndc (package): 65954-014-95 ndc (package): 65954-014-75 ndc (package): 65954-014-63 ndc (package): 65954-014-78 ndc (package): 65954-014-60 ndc (package): 65954-014-58 ndc (package): 65954-014-01 ndc (package): 65954-014-99 ndc (product): 65954-014 ndc11 (package): 65954001478 ndc11 (package): 65954001475 ndc11 (package): 65954001499 ndc11 (package): 65954001458 ndc11 (package): 65954001495 ndc11 (package): 65954001460 ndc11 (package): 65954001401 ndc11 (package): 65954001463 spl id: 6f04db7b-c705-4038-8a35-cd8a62b4bd81 spl set id: d142e43f-415a-41c5-a7db-8b18a039a323

Reported adverse events (FAERS/openFDA)#

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