COLGATE TOTAL 12 HR PRO-SHIELD SPEARMINT SURGE- 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™ 12 Hr Pro-Shield Spearmint Surge

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, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6

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

12 HR PROTECTION*
EVEN
AFTER
EATING & DRINKING

ANTIBACTERIAL

Kills 99% of Germs on Contact

Significantly Reduces Plaque

Helps Prevent Gingivitis

10X LONGER LASTING COOL**

SPEARMINT

33.8 FL OZ (1.05 QT) 1L

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
COLGATE TOTAL 12 HR PRO-SHIELD SPEARMINT SURGE 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-731
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)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-731-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2015
2NDC:35000-731-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2015
3NDC:35000-731-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2015
4NDC:35000-731-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2015
5NDC:35000-731-501500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35609/01/2015
Labeler - Colgate-Palmolive Company (001344381)

Revised: 2/2022
Document Id: 30f60b06-510b-4a9a-ba8a-80b737255f99
Set id: 91fcccfe-aaef-45ee-a5d2-70a3939439ee
Version: 5
Effective Time: 20220217
 
Colgate-Palmolive Company