Colgate Total Advanced Gum Health Mouthwash

Manufacturer
Colgate-Palmolive Company
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 00:22:28

Label at a glance#

ProductColgate Total Advanced Gum Health Mouthwash
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

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

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • 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 oldervigorously 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 agesupervise use
children under 6 years of agedo 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, citric acid, sodium saccharin, sucralose, FD&C green no. 3

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

Colgate®
Antigingivitis Antiplaque Mouthwash

Total

GUM HEALTH
HELPS FIGHT PLAQUE AND GINGIVITIS

ANTIBACTERIAL
45% Stronger, Healthier Gums*

Fights Plaque Between Teeth & Along the Gum Line

Helps Prevent Gingivitis

10X LONGER LASTING COOL**

CLEAN MINT

16.9 FL OZ
(1.05 PT) 500 mL

P80040906

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1599135cetylpyridinium chloride 0.075 % MouthwashPSN11
1599137Colgate Total Advanced Pro-Shield 0.075 % MouthwashPSN11
1599137cetylpyridinium chloride 0.75 MG/ML Mouthwash [Colgate Total Mouthwash]SBD11
1599135cetylpyridinium chloride 0.75 MG/ML MouthwashSCD11
1599135cetylpyridinium chloride 0.075 % MouthwashSY11
1599137Colgate Total 0.75 MG/ML MouthwashSY11
1599137Colgate Total Advanced Pro-Shield 0.075 % MouthwashSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-723-02Colgate Total Advanced Gum Health Mouthwash60 mL in 1 BOTTLERINSE6011
35000-723-16Colgate Total Advanced Gum Health Mouthwash500 mL in 1 BOTTLERINSE50011
35000-723-33Colgate Total Advanced Gum Health Mouthwash1000 mL in 1 BOTTLERINSE100011
35000-723-84Colgate Total Advanced Gum Health Mouthwash250 mL in 1 BOTTLERINSE25011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-723COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH (CETYLPYRIDINIUM CHLORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]11Current NDC, Legacy NDC, 4 package rows20241004_51296af5-4d95-4e9c-97c4-7defc13c9b7e.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-72335000-723-16, 35000-723-33, 35000-723-02, 35000-723-84

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total Advanced Gum Health MouthwashCETYLPYRIDINIUM CHLORIDEColgate-Palmolive Company51296af5-4d95-4e9c-97c4-7defc13c9b7e2024-10-01WarningsExact identifier
ndc (package): 35000-723-16
ndc (package): 35000-723-84
ndc (package): 35000-723-02
ndc (package): 35000-723-33
ndc (product): 35000-723
ndc11 (package): 35000072316
ndc11 (package): 35000072302
ndc11 (package): 35000072384
ndc11 (package): 35000072333
spl id: ad74fe6e-e781-48af-908c-16d59d06e8f0
spl set id: 51296af5-4d95-4e9c-97c4-7defc13c9b7e

Reported adverse events (FAERS/openFDA)#

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