FDA.reportPublic FDA data

Colgate Total Active Prevention Gum Health

Manufacturer
Colgate-Palmolive Company
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:32:24

Label at a glance#

ProductColgate Total Active Prevention Gum Health
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

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Zinc Lactate, Flavor, Potassium Sorbate, Lactic Acid, Sodium Saccharin, Sucralose, Green 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

ALCOHOL FREE

Colgate®
Antigingivitis Antiplaque Mouthwash

Total
ACTIVE PREVENTION

GUM HEALTH

Helps Prevent Gingivitis

24 HOUR ANTIBACTERIAL PROTECTION1

Fight Rood Cause2 of:

✓Gingivitis ✓Plaque ✓Tartar Buildup

ADA
Accepted
American
Dental
Association

CLINICALLY
PROVEN

16.9 FL OZ (1.05 PT) 500 mL

PS0073268

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-281-16Colgate Total Active Prevention Gum Health500 mL in 1 BOTTLERINSE5001
35000-281-31Colgate Total Active Prevention Gum Health1000 mL in 1 BOTTLERINSE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-281COLGATE TOTAL ACTIVE PREVENTION GUM HEALTH (CETYLPYRIDINIUM CHLORIDE) RINSE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 2 package rows20241101_fb63b8bb-826a-42e6-a429-b8d86c5c9223.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-28135000-281-16, 35000-281-31

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
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
ZINC LACTATE2GXR25858YIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C GREEN NO. 33P3ONR6O1SIACT

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 Active Prevention Gum HealthCETYLPYRIDINIUM CHLORIDEColgate-Palmolive Companyfb63b8bb-826a-42e6-a429-b8d86c5c92232024-10-04WarningsExact identifier
ndc (package): 35000-281-16
ndc (package): 35000-281-31
ndc (product): 35000-281
ndc11 (package): 35000028131
ndc11 (package): 35000028116
spl id: 1fd3db84-50ed-40bd-b913-8dea8203c96e
spl set id: fb63b8bb-826a-42e6-a429-b8d86c5c9223

Reported adverse events (FAERS/openFDA)#

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