Colgate® Total™ FRESHMINT

Drug Labeling and Warnings

Drug Details [pdf]

COLGATE TOTAL  FRESHMINT- cetylpyridinium chloride mouthwash 
Colgate Oral Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate®
Total™
FRESHMINT

Drug Facts

Active ingredient (in each 20 mL)

cetylpyridinium chloride (0.05% w/w)

Purpose

Antigingivitis/Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

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.

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.

Directions

adults and children 12 years of age and older
  • vigorously swish 20 mL (4 teaspoons) 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

  • store at controlled room temperature 20-25° C (68-77° F)
  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, polysorbate 20, sodium benzoate, flavor, phosphoric acid, menthol, sodium saccharin, FD&C blue no. 1, FD&C yellow no. 5

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 887 mL Bottle Label

Colgate®

Total™

Cetylpyridinium Chloride Antigingivitis / Antiplaque Mouthwash
ALCOHOL FREE

Significantly reduces
plaque

Helps reduce
gingivitis

Delivers long-lasting
fresh breath

12 HOUR PROTECTION
Against Plaque and Bacteria

CLINICALLY TESTED

FRESHMINT

30 FL OZ (1.87 PT) 887 mL

10001486

Principal Display Panel - 887 mL Bottle Label
COLGATE TOTAL   FRESHMINT
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0126-0023
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE10.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGREEN (transparent, no particulates) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0126-0023-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201008/01/2019
2NDC: 0126-0023-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201008/01/2019
3NDC: 0126-0023-14887 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/201008/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/201008/01/2019
Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 9/2019
Document Id: 104cdb5f-27fd-43ae-9570-3d4e62590723
Set id: bd29c170-7823-4bf4-95f9-f4a2c4f5d08b
Version: 2
Effective Time: 20190909