Colgate® Total Ultra Fresh

Colgate Total Ultra Fresh by

Drug Labeling and Warnings

Colgate Total Ultra Fresh by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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Colgate® Total Ultra Fresh

Drug Facts

Active ingredient

Cetylpyridinium Chloride 0.075%

Purpose

Antigingivitis/Antiplaque

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

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

  • this rinse is not intended to replace brushing or flossing
  • store at 59°F to 77°F
  • keep from freezing

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 mL
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: 35000-735-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202206/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUG505G(a)(3)01/01/202206/30/2024
Labeler - Colgate-Palmolive Company (001344381)

Revised: 1/2023
Document Id: 77ce5f4f-39c9-4f4d-925a-b61ef9a25750
Set id: d6c5d3b5-362a-801b-9101-4c733c1b080d
Version: 9
Effective Time: 20230130