Colgate Total 12 Hr Pro-Shield Spearmint Surge

Manufacturer: Colgate-Palmolive Company
Effective date: 2025-02-19
Label type: HUMAN OTC DRUG LABEL
Version: 15
Source: full-release
Hydrated at: 2026-06-01 01:37:46

Label at a glance#

ProductColgate Total 12 Hr Pro-Shield Spearmint Surge

Active ingredientCETYLPYRIDINIUM CHLORIDE

Label structure11 sections

Indications and uses

helps prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums

Dosage and administration

adults and children 12 years of age and older vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. children 6 years to under 12 years of age supervise use children under 6 years of age do not use

Storage and handling

this rinse is not intended to replace brushing or flossing store at 59°F to 77°F keep from freezing

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

Cetylpyridinium chloride 0.075%

Purpose

OTC - PURPOSE SECTION

Antigingivitis/Antiplaque

Uses

INDICATIONS & USAGE SECTION

helps prevent and reduce plaque and gingivitis
helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums

Warnings

WARNINGS SECTION

OTC - STOP USE SECTION

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older	vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
children 6 years to under 12 years of age	supervise use
children under 6 years of age	do not use

Other information

STORAGE AND HANDLING SECTION

this rinse is not intended to replace brushing or flossing
store at 59°F to 77°F
keep from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, propylene glycol, sorbitol, poloxamer 407, flavor, potassium sorbate, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

Colgate^®
Antigingivitis Antiplaque Mouthwash

Total

12 HR PROTECTION*
EVEN AFTER EATING AND DRINKING

ANTIBACTERIAL

Kills 99% of Germs on Contact
Significantly Reduces Plaque
Helps Prevent Gingivitis

10X LONGER LASTING COOL**

SPEARMINT

P80040924

16.9 FL OZ
(1.05 PT) 500 mL

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1599135	cetylpyridinium chloride 0.075 % Mouthwash	PSN	15
1599137	Colgate Total Advanced Pro-Shield 0.075 % Mouthwash	PSN	15
1599137	cetylpyridinium chloride 0.75 MG/ML Mouthwash [Colgate Total Mouthwash]	SBD	15
1599135	cetylpyridinium chloride 0.75 MG/ML Mouthwash	SCD	15
1599135	cetylpyridinium chloride 0.075 % Mouthwash	SY	15
1599137	Colgate Total 0.75 MG/ML Mouthwash	SY	15
1599137	Colgate Total Advanced Pro-Shield 0.075 % Mouthwash	SY	15

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	0029095		colgate-01.jpg
Data code	Data Matrix	0040924		colgate-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35000-731-02	Colgate Total 12 Hr Pro-Shield Spearmint Surge	60 mL in 1 BOTTLE	RINSE	60	15
35000-731-16	Colgate Total 12 Hr Pro-Shield Spearmint Surge	500 mL in 1 BOTTLE	RINSE	500	15
35000-731-33	Colgate Total 12 Hr Pro-Shield Spearmint Surge	1000 mL in 1 BOTTLE	RINSE	1000	15
35000-731-50	Colgate Total 12 Hr Pro-Shield Spearmint Surge	1500 mL in 1 BOTTLE	RINSE	1500	15
35000-731-84	Colgate Total 12 Hr Pro-Shield Spearmint Surge	250 mL in 1 BOTTLE	RINSE	250	15

Products#

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

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

Colgate Total 12 Hr Pro-Shield Spearmint Surge
CETYLPYRIDINIUM CHLORIDE
CETYLPYRIDINIUM
WATER
GLYCERIN
PROPYLENE GLYCOL
SORBITOL
POLOXAMER 407
POTASSIUM SORBATE
SACCHARIN SODIUM
ANHYDROUS CITRIC ACID
SUCRALOSE
FD&C GREEN NO. 3
FD&C YELLOW NO. 6

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
35000-731	35000-731-02, 35000-731-84, 35000-731-16, 35000-731-33, 35000-731-50

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
CETYLPYRIDINIUM CHLORIDE	D9OM4SK49P	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITOL	506T60A25R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Total 12 Hr Pro-Shield Spearmint Surge	CETYLPYRIDINIUM CHLORIDE	Colgate-Palmolive Company	91fcccfe-aaef-45ee-a5d2-70a3939439ee	2025-02-19	Warnings	Exact identifier ndc (package): 35000-731-50 ndc (package): 35000-731-02 ndc (package): 35000-731-33 ndc (package): 35000-731-84 ndc (package): 35000-731-16 ndc (product): 35000-731 ndc11 (package): 35000073184 ndc11 (package): 35000073150 ndc11 (package): 35000073102 ndc11 (package): 35000073133 ndc11 (package): 35000073116 spl id: 50ba6069-a202-47de-8fd0-cf7605b30451 spl set id: 91fcccfe-aaef-45ee-a5d2-70a3939439ee

Reported adverse events (FAERS/openFDA)#

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