FDA.reportPublic FDA data

Colgate Total Advanced Gum Health Mouthwash

Manufacturer
Team Technologies, Inc
Effective date
2016-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:56

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

Dosage and administration

adults and children 12 years of age and older rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day. Do not swallow. 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

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a dentist if condition persists or worsens after regular use.

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 olderrinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day. Do not swallow.
children 6 years to under 12 years of agesupervise use
children under 6 years of agedo not use

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

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

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

Colgate®
Antigingivitis Antiplaque Mouthwash

Total®

GUM HEALTH

Advanced Gum Protection for
45% Stronger, Healthier Gums*

  1. Fights plaque between teeth & along
    the gum line
  2. Kills 99% of germs on contact
  3. 12-hour protection against bacteria
    that cause gingivitis

CLEAN MINT

16.9 FL OZ
(1.05 PT)
500 mL

P9903746

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 % MouthwashPSN1
1599137Colgate Total Advanced Pro-Shield 0.075 % MouthwashPSN1
1599137cetylpyridinium chloride 0.75 MG/ML Mouthwash [Colgate Total Mouthwash]SBD1
1599135cetylpyridinium chloride 0.75 MG/ML MouthwashSCD1
1599135cetylpyridinium chloride 0.075 % MouthwashSY1
1599137Colgate Total 0.75 MG/ML MouthwashSY1
1599137Colgate Total Advanced Pro-Shield 0.075 % MouthwashSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67659-502-302020-01-31C16284748780-19d75b9d1-1c56-f424-e053-dadaa90a57ceColgate ® Total ® Advanced Gum Health Mouthwash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67659-502-30Colgate Total Advanced Gum Health Mouthwash1000 mL in 1 BOTTLERINSE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67659-502COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH (CETYLPYRIDINIUM CHLORIDE) RINSE [TEAM TECHNOLOGIES, INC]1Legacy NDC, 1 package rows20160517_330dda24-9b4b-2dca-e054-00144ff8d46c.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
67659-50267659-502-30
35000-723

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
POLOXAMER 407TUF2IVW3M2IACT
FD&C GREEN NO. 33P3ONR6O1SIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

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 · 2 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 (product): 35000-723
330dda24-9b4c-2dca-e054-00144ff8d46c330dda24-9b4b-2dca-e054-00144ff8d46c2016-05-17WarningsExact identifier
spl id: 330dda24-9b4c-2dca-e054-00144ff8d46c
spl set id: 330dda24-9b4b-2dca-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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