COLGATE TOTAL ULTRA FRESH- cetylpyridinium chloride rinse 
Colgate-Palmolive Company

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 Ultra Fresh

Drug Facts

Active ingredient

Cetylpyridinium Chloride 0.075%

Purpose

Antigingivitis/Antiplaque

Uses

Warnings

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.

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

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

Inactive ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Flavor, Potassium Sorbate, Citric Acid, Sodium Saccharin, Charcoal Powder, Blue 1, Red 40, Yellow 5.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

ALCOHOL FREE

Colgate®
Antigingivitis Antiplaque Mouthwash

Total
WHOLE MOUTH HEALTH

ULTRA FRESH
PROVIDES AN INSTANT AND
LONG-LASTING FRESH FEELING

CETYLPYRIDINIUM CHLORIDE MOUTHWASH

ANTIBACTERIAL

Kills 99% of Bacteria
Significantly Reduces Plaque
Helps Prevent Gingivitis

10X LONGER LASTING COOL*

PEPPERMINT • CHARCOAL

33.8 FL OZ (1.05 QT) 1L

PS0028155

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
COLGATE TOTAL ULTRA FRESH 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-735
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE15 mg  in 20 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorBLACKScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-735-331 L in 1 BOTTLE; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35601/01/2022
Labeler - Colgate-Palmolive Company (001344381)

Revised: 1/2022
Document Id: ca93ec91-7126-4269-b909-1f91830073a4
Set id: d6c5d3b5-362a-801b-9101-4c733c1b080d
Version: 1
Effective Time: 20220112
 
Colgate-Palmolive Company